A Phase 3 interventional study of Recombinant Factor VIIa and Placebo in Burns, sponsored by United States Army Institute of Surgical Research. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by United States Army Institute of Surgical Research · Phase 3, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →United States Army Institute of Surgical Research is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: Recombinant Factor VIIa
intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)
Drug: Placebo
intravenous infusion of Factor VIIa
intravenous infusion of placebo (sterile water)
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
Time frame: 24 hours
Patients with greater than 20% TBSA burn scheduled for excision and grafting will be randomized in the operating room.
| Milestone | Experimental | Control- Placebo |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| units of blood components | Experimental | Control- Placebo |
|---|---|---|
| Units of PRBC | 68.9 | 87.2 |
| Units of cryoprecipitate | 0 | 4.1 |
| Units of platelets | 1.02 | 6.45 |
| Units of fresh frozen plasma | 13.02 | 33.44 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | — | 7/10 (70%) | 7/10 (70%) |
| Control | — | 5/10 (50%) | 8/10 (80%) |
| Event | Experimental | Control |
|---|---|---|
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 4/10 | 3/10 |
| Deep Vein ThrombosisBlood and lymphatic system disorders | 2/10 | 1/10 |
| SepsisImmune system disorders | 2/10 | 0/10 |
| Muscle NecrosisMusculoskeletal and connective tissue disorders | 1/10 | 1/10 |
| BacteremiaImmune system disorders | 1/10 | 0/10 |
| Acute Kidney InjuryRenal and urinary disorders | 1/10 | 0/10 |
| MICardiac disorders | 1/10 | 1/10 |
| Vascular DisordersVascular disorders | 1/10 | 0/10 |
| Event | Experimental | Control |
|---|---|---|
| InfectionImmune system disorders | 7/10 | 5/10 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 2/10 | 1/10 |
| Decreased Oxygen SaturationRespiratory, thoracic and mediastinal disorders | 2/10 | 1/10 |
| HypotensionBlood and lymphatic system disorders | 2/10 | 2/10 |
| Rule Out Myocardial InfarctionCardiac disorders | 0/10 | 1/10 |
| Disseminated Intravascular CoagulationBlood and lymphatic system disorders | 1/10 | 0/10 |
| HydrothoraxRespiratory, thoracic and mediastinal disorders | 0/10 | 1/10 |
| Renal InsufficiencyRenal and urinary disorders | 1/10 | 0/10 |
| Liver InjuryHepatobiliary disorders | 1/10 | 1/10 |
| ConstipationGastrointestinal disorders | 1/10 | 0/10 |
| Age, Categorical(Participants) | Experimental | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Experimental | Control | Total |
|---|---|---|---|
| Mean | 29.6 ± 8.33 | 28.8 ± 10.24 | 29.1 ± 9.32 |
| Sex: Female, Male(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 9 | 10 | 19 |
| Region of Enrollment(participants) | Experimental | Control | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
Plan to share: No
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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United States Army Institute of Surgical Research