Burns
Conditions
Keywords
Burns
Brief summary
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.
Detailed description
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.
Interventions
intravenous infusion of Factor VIIa
DRUGPlacebo
intravenous infusion of placebo (sterile water)
Sponsors
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Burn wounds * 18-65 years of age * Scheduled excision of burn wound of at least 20 percent TBSA
Exclusion criteria
* Age greater than 65 years * History of blood coagulation disorders * Taking anti-coagulation medication * Contraindication for heparin therapy * Pregnant or nursing females * Unstable angina * MI within the last 6 months * Recent of diagnosis of DVT, stroke within the last 6 months * Renal failure requiring dialysis or creatinine clearance less than 25 ml/min * Religious prohibition to blood transfusion * Have received rFVIIa during current hospitalization * Previous enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | 24 hours |
Countries
United States
Participant flow
Recruitment details
Patients with greater than 20% TBSA burn scheduled for excision and grafting will be randomized in the operating room.
Pre-assignment details
If the excision and grafting was not the first for the patient.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Recombinant Factor VIIa : intravenous infusion of Factor VIIa | 10 |
| Control | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 28.8 years STANDARD_DEVIATION 10.24 | 29.6 years STANDARD_DEVIATION 8.33 | 29.1 years STANDARD_DEVIATION 9.32 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 10 | 8 / 10 |
| serious Total, serious adverse events | 7 / 10 | 5 / 10 |
Outcome results
Primary
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
Time frame: 24 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of PRBC | 68.9 units of blood components |
| Experimental | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of cryoprecipitate | 0 units of blood components |
| Experimental | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of platelets | 1.02 units of blood components |
| Experimental | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of fresh frozen plasma | 13.02 units of blood components |
| Control- Placebo | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of fresh frozen plasma | 33.44 units of blood components |
| Control- Placebo | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of PRBC | 87.2 units of blood components |
| Control- Placebo | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of platelets | 6.45 units of blood components |
| Control- Placebo | Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively | Units of cryoprecipitate | 4.1 units of blood components |