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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00243243
First received: October 19, 2005
Last updated: March 28, 2013
Last verified: March 2013
Results First Received: August 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Burns
Intervention: Drug: Recombinant Factor VIIa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with greater than 20% TBSA burn scheduled for excision and grafting will be randomized in the operating room.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If the excision and grafting was not the first for the patient.

Reporting Groups
  Description
Experimental Recombinant Factor VIIa : intravenous infusion of Factor VIIa
Control- Placebo Intravenous infusion of a placebo

Participant Flow:   Overall Study
    Experimental     Control- Placebo  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Experimental Recombinant Factor VIIa : intravenous infusion of Factor VIIa
Control No text entered.
Total Total of all reporting groups

Baseline Measures
    Experimental     Control     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.6  ± 8.33     28.8  ± 10.24     29.1  ± 9.32  
Gender  
[units: participants]
     
Female     1     0     1  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures

1.  Primary:   Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
N/A


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David G. Baer, PhD, Director Research
Organization: US Army Institute of Surgical Research
phone: 210-539-4327
e-mail: david.g.baer@us.army.mil


Publications:

Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00243243     History of Changes
Other Study ID Numbers: H-05-027
Study First Received: October 19, 2005
Results First Received: August 28, 2012
Last Updated: March 28, 2013
Health Authority: United States: Federal Government