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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002059-41 | EudraCT Number |
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See termination reason in detailed description
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This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.
Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFVIIa, Blunt Trauma | Experimental |
| |
| Placebo, Blunt Trauma | Placebo Comparator |
| |
| rVIIa, Penetrating Trauma | Experimental |
| |
| Placebo, Penetrating Trauma | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug | Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection. Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of participants to die from day 0 to day 30 from all causes. | from day 0 to 30 |
| Morbidity | Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30. | from day 0 to day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention | The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30. | from day 0 to day 30 |
| Time to Death From Time of First Dose |
Not provided
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Princeton | New Jersey | 08540 | United States | ||
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Eligible subjects were those with either blunt and/or penetrating trauma injuries and confirmed clinical indicators for active haemorrhage refractory to standard treatment (including blood component therapy and surgical haemostatic procedures).
150 trial sites globally.
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| ID | Title | Description |
|---|---|---|
| FG000 | rFVIIa, Blunt Trauma | Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | placebo |
|
The time of first dose refers to the time of the first dose of rFVIIa or placebo. |
| from day 0 to day 30 |
| Number of Units of Transfused Red Blood Cells From Time of First Dose | The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo. | from hour 0 to 24 |
| Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury | The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury. | from hour 0 to 24 |
| Number of Units of All Allogeneic Transfusions From Time of First Dose | The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo. | from hour 0 to 24 |
| Säo Paulo |
| 05001-400 |
| Brazil |
| Prague | 16000 | Czechia |
| Paris La Défense Cedex | 92932 | France |
| Mainz | 55127 | Germany |
| Vouliagment | 16671 | Greece |
| Kowloon | Hong Kong |
| Budapest | 1025 | Hungary |
| Rome | 00144 | Italy |
| Alphen aan den Rijn | Netherlands |
| Sandton | 2146 | South Africa |
| Madrid | 28033 | Spain |
| Zurich | CH-8050 | Switzerland |
| Crawley | RH11 9RT | United Kingdom |
| FG001 | Placebo, Blunt Trauma | Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. |
| FG002 | rVIIa, Penetrating Trauma | Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. |
| FG003 | Placebo, Penetrating Trauma | Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | rFVIIa, Blunt Trauma | |
| BG001 | Placebo, Blunt Trauma | |
| BG002 | rFVIIa, Penetrating Trauma | |
| BG003 | Placebo, Penetrating Trauma | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Number of participants to die from day 0 to day 30 from all causes. | Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Patients who discontinued (withdrawn or lost to follow up) before day 30 were excluded from analyses. Penetrating Trauma patient population: No analysis done due to low statistical power. | Posted | Number | Participants | from day 0 to 30 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Morbidity | Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30. | Blunt trauma patient population: According to protocol, morbidity is not part of the primary endpoint since non-inferiority test of mortality was not passed. Penetrating Trauma patient population: No analysis done due to low statistical power. | Posted | from day 0 to day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention | The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30. | Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Penetrating Trauma patient population: No analysis done due to low statistical power. | Posted | Mean | Standard Deviation | Days | from day 0 to day 30 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Death From Time of First Dose | The time of first dose refers to the time of the first dose of rFVIIa or placebo. | There is no measure summary for time to event type of endpoint as this would be a Kaplan-Meier graph. | Posted | from day 0 to day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Units of Transfused Red Blood Cells From Time of First Dose | The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo. | Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power. | Posted | Mean | Standard Deviation | Units of transfused red blood cells | from hour 0 to 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury | The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury. | Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power. | Posted | Number | Participants | from hour 0 to 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Units of All Allogeneic Transfusions From Time of First Dose | The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo. | Blunt trauma patient population: Intention-to-treat (ITT) analysis set, including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power. | Posted | Mean | Standard Deviation | Units of allogeneic transfusions | from hour 0 to 24 |
|
|
Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rFVIIa, Blunt Trauma | Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. | 147 | 224 | 108 | 224 | ||
| EG001 | Placebo, Blunt Trauma | Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. | 177 | 250 | 125 | 250 | ||
| EG002 | rVIIa, Penetrating Trauma | Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. | 18 | 46 | 26 | 46 | ||
| EG003 | Placebo, Penetrating Trauma | Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose. | 20 | 40 | 24 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electromechanical dissociation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperadrenalism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal compartment syndrome | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Duodenal fistula | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peritoneal effusion | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Brain death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound necrosis | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic ischaemia | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Septic necrosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin graft infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound infection bacterial | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aortic injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diffuse axonal injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fat embolism | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Iatrogenic injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Inadequate analgesia | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary bladder rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vena cava injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vertebral injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weaning failure | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound decomposition | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac output decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sputum culture positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle necrosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic deformity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral hygroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anoxic encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Brain stem haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Critical illness polyneuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoxic encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neuromyopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Quadriparesis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subdural effusion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary fistula | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic haemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Internal fixation of fracture | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Exsanguination | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Venous haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Trial was terminated after planned interim analysis for futility showed a lower than expected conditional power for showing superiority (11.2% [actual] vs. 50% [required]). 554 of 1502 planned patients were included in the intent-to-treat population.
Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial in accordance with the latest Vancouver guidelines. Any such scientific paper, resentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication / presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Treatment groups are compared using a Cox Proportional Hazards model with treatment as factor and adjusting for age, Injury Severity Score (ISS), Glasgow Coma -Scale Score(GCS), International Normalized Ratio (INR) and acute lung injury. | Cox Proportional Hazards Model | 0.589 | Two-sided significance level 5% | Hazard Ratio (HR) | 1.18 | 95 | 0.64 | 2.17 | No | Superiority or Other |
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