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The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.
To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFVIIa | Experimental | intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery) |
|
| Control | Placebo Comparator | intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Factor VIIa | Drug | intravenous infusion of Factor VIIa |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung S Park, MD | United States Army Institute of Surgical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12458988 | Background | Deveras RA, Kessler CM. Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate. Ann Intern Med. 2002 Dec 3;137(11):884-8. doi: 10.7326/0003-4819-137-11-200212030-00009. |
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If the excision and grafting was not the first for the patient.
Patients with greater than 20% TBSA burn scheduled for excision and grafting will be randomized in the operating room.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Recombinant Factor VIIa : intravenous infusion of Factor VIIa |
| FG001 | Control- Placebo | Intravenous infusion of a placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Recombinant Factor VIIa : intravenous infusion of Factor VIIa |
| BG001 | Control | |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Posted | Number | units of blood components | 24 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Recombinant Factor VIIa : intravenous infusion of Factor VIIa |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David G. Baer, PhD, Director Research | US Army Institute of Surgical Research | 210-539-4327 | david.g.baer@us.army.mil |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C103587 | recombinant FVIIa |
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| Placebo |
| Drug |
intravenous infusion of placebo (sterile water) |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 7 |
| 10 |
| 7 |
| 10 |
| EG001 | Control | 5 | 10 | 8 | 10 |
| Sepsis | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Muscle Necrosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bacteremia | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| MI | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rule Out Myocardial Infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Decreased Oxygen Saturation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
|
| Hypotension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Liver Injury | Hepatobiliary disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Upper Extremity Edema | General disorders | Systematic Assessment |
|
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