Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TachoSil® | Active Comparator |
| |
| Standard Treatment | Active Comparator | Standard Treatment of haemorrhage in cardiovascular surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fibrinogen (human) + thrombin (human) | Drug |
| ||
| Standard haemostatic treatment in cardiovascular surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Haemostasis at 3 Minutes | Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved. | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Haemostasis at 6 Minutes. | Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved. | 6 minutes |
Not provided
Inclusion Criteria:
All inclusion criteria must be answered "yes" for a subject to participate in the trial.
At Screening:
Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
For female subjects of childbearing potential: Is the pregnancy test at screening negative?
Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
Is the subject ≥ 18 years of age?
Is the following planned: An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure?
Intra operative (after primary haemostatic treatment):
Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?
Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).
Is it possible to compress the randomised treatment (TachoSil® or control fleece material) for 3 minutes?
Exclusion Criteria:
All exclusion criteria must be answered "no" for a subject to participate in the trial.
At Screening:
Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?
Does the subject participate in a clinical trial concomitantly with the present trial?
Is the subject undergoing an emergency operation?
Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
Is the subject suffering from known coagulopathy?
Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?
Is the female subject pregnant or breast feeding?
Intra operative (after primary haemostatic treatment):
Has liquid fibrin sealant/glue or TachoSil® been applied?
Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nycomed Clinical Trial Operations | Headquaters | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed | Roskilde | 4000 | Denmark |
From the total of 120 enrolled subjects, data are presented for 119 randomised subjects that received trial treatment (= Intention to Treat (ITT) population).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TachoSil® | Absorbable sponge for intra-operative topical application |
| FG001 | Comparator | Standard haemostatic treatment in cardiovascular surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TachoSil® | |
| BG001 | Standard Treatment | |
| BG002 | 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, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | All patients were Caucasian | Number | participants |
| ||||||||||||||||||
| Classification of surgery | Planned elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure. The information about planned surgery reflects the protocol defined eligibility criterion no. 5. In addition, the actually performed surgery is categorized into simple and combined/complex cardiovascular procedures. The proportions of patients undergoing combined/complex cardiovascular procedures in the TachoSil® group and the Standard Treatment group, respectively, were 44 and 59 percent. The calculated total (103) is irrelevant and inappropriate arithmetic. | Number | Percentage of subjects |
| ||||||||||||||||||
| Evaluation of bleeding at target area before randomization | In order to avoid selection bias, evaluation of bleeding at target area was performed after completion of primary hemostasis and prior to randomization. Data obtained prior to final assessment of patient eligibility and randomization. More than one record/condition per patient possible. | Number | participants |
| ||||||||||||||||||
| Identification of target area for efficacy evaluation | In order to avoid selection bias, intra-operative randomization was only performed if supportive haemostatic treatment was required after completion of primary haemostasis. Data obtained prior to final assessment of patient eligibility and randomization. More than one record/condition per patient possible. | Number | participants |
| ||||||||||||||||||
| Primary haemostatic treatment | Data obtained prior to final assessment of patient eligibility and randomization. More than one record/condition per patient possible. | Number | participants |
| ||||||||||||||||||
| Type of tissue | Type of tissue treated with randomized treatment | Number | 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 | Proportion of Subjects Achieving Haemostasis at 3 Minutes | Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved. | Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined "as randomised" and the Safety population (= basis for Adverse Events analyses) was defined "as treated". | Posted | Number | 95% Confidence Interval | Proportion of Subjects | 3 minutes |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Achieving Haemostasis at 6 Minutes. | Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved. | Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined "as randomised" and the Safety population (= basis for Adverse Events analyses) was defined "as treated". | Posted | Number | 95% Confidence Interval | Proportion of Subjects | 6 minutes |
|
|
Not provided
SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone).
Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
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 | TachoSil® | 8 | 62 | 38 | 62 | |||
| EG001 | Standard Treatment | 18 | 57 | 30 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Atrioventricular block third degree | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Low cardiac output syndrome | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Cardiac function disturbance postoperative | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Haemothorax | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Post procedural stroke | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Stent-graft endoleak | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment | non-serious |
|
| Bradycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment | non-serious |
|
| Haemoglobin decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment | non-serious |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.1) | Systematic Assessment | non-serious |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Responsible | Medical Scientific Strategy | +45 4677 1111 | clinicaltrials@nycomed.com |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| D013917 | Thrombin |
| D013504 | Cardiovascular Surgical Procedures |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001779 | Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Male |
|
| Venous |
|
| Mild haemorrhage |
|
| Moderate haemorrhage |
|
| Severe haemorrhage |
|
| Coronary anastomosis |
|
| Internal mammary artery vascular bed |
|
| Left atrium |
|
| Left ventricle |
|
| Right atrium |
|
| Right ventricle |
|
| Other |
|
| Electro-coagulation |
|
| Clips |
|
| Gauze |
|
| None |
|
| Vessel |
|
|
|