Open Label Use Of RiaStap During Aortic Reconstruction

This study has been completed.
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01300286
First received: January 9, 2011
Last updated: May 15, 2014
Last verified: January 2014
Results First Received: January 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coagulopathic Bleeding
Intervention: Drug: RiaSTAP

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RiaSTAP RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.

Participant Flow:   Overall Study
    RiaSTAP  
STARTED     23  
COMPLETED     22  
NOT COMPLETED     1  
did not get dosed                 1  



  Baseline Characteristics
  Hide 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
RiaSTAP RiaSTAP: One time dose of 70 mg/kg will be administered intravenously

Baseline Measures
    RiaSTAP  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 13  
Gender  
[units: participants]
 
Female     7  
Male     16  
Region of Enrollment  
[units: participants]
 
United States     23  



  Outcome Measures

1.  Primary:   Fibrinogen Level Change   [ Time Frame: Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline) ]

2.  Secondary:   Total Blood Product Units Administered.   [ Time Frame: Operating room admission thru 48 hour . ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Ian Welsby
Organization: Duke University Medical Center
phone: 919-668-2699
e-mail: ian.welsby@duke.edu


Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01300286     History of Changes
Other Study ID Numbers: Pro00024305
Study First Received: January 9, 2011
Results First Received: January 16, 2014
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board