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Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn

Primary Purpose

Burns

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Recombinant Factor VIIa

Placebo

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

United States Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rFVIIa

Control

Arm Description

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)

intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)

Outcomes

Primary Outcome Measures

Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively

Secondary Outcome Measures

Full Information

NCT ID

NCT00243243

First Posted

October 19, 2005

Last Updated

April 26, 2016

Sponsor

United States Army Institute of Surgical Research

1. Study Identification

Unique Protocol Identification Number

NCT00243243

Brief Title

Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn

Official Title

Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United States Army Institute of Surgical Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

Keywords

Burns

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rFVIIa

Arm Type

Experimental

Arm Description

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)

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)

Intervention Type

Drug

Intervention Name(s)

Recombinant Factor VIIa

Intervention Description

intravenous infusion of Factor VIIa

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

intravenous infusion of placebo (sterile water)

Primary Outcome Measure Information:

Title

Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myung S Park, MD

Organizational Affiliation

United States Army Institute of Surgical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

United States Army Institute of Surgical Research

City

Ft Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12458988

Citation

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.

Results Reference

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Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn

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