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

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ClinicalTrials.gov Identifier: NCT00243243
Recruitment Status : Completed
First Posted : October 21, 2005
Results First Posted : March 6, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Burns
Interventions: Drug: Recombinant Factor VIIa
Drug: Placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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
No text entered.


  More Information

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
First Submitted: October 19, 2005
First Posted: October 21, 2005
Results First Submitted: August 28, 2012
Results First Posted: March 6, 2013
Last Update Posted: May 26, 2016