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Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

This study has been terminated.
(Too many barriers to enroll participants.)
Sponsor:
Collaborator:
rEVO Biologics
Information provided by (Responsible Party):
William C. Oliver, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01547728
First received: February 7, 2012
Last updated: July 13, 2015
Last verified: July 2015
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Thrombophilia Due to Acquired Antithrombin III Deficiency
Intervention: Drug: Recombinant antithrombin (rhAT)

  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
Subjects were recruited from Mayo Clinic in Rochester, Minnesota.

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
Recombinant Antithrombin (rhAT) Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.

Participant Flow:   Overall Study
    Recombinant Antithrombin (rhAT)
STARTED   42 
COMPLETED   1 
NOT COMPLETED   41 
Change in procedure and equipment                1 
Drug not ready for subject                1 
Screen failure                39 



  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
Recombinant Antithrombin (rhAT) Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.

Baseline Measures
   Recombinant Antithrombin (rhAT) 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Years]
Mean (Full Range)
 64 
 (19 to 83) 
Gender 
[Units: Participants]
 
Female   15 
Male   27 
Region of Enrollment 
[Units: Participants]
 
United States   42 


  Outcome Measures

1.  Primary:   Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration   [ Time Frame: 3 minutes after the initial dose of rhAT, Day 1 of the study ]


  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
The study was terminated because there were too many barriers to enroll participants.


  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: Dr. William Oliver
Organization: Mayo Clinic Rochester
phone: 507-255-4240
e-mail: oliver.william@mayo.edu



Responsible Party: William C. Oliver, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01547728     History of Changes
Other Study ID Numbers: 11-004125
Study First Received: February 7, 2012
Results First Received: April 21, 2015
Last Updated: July 13, 2015
Health Authority: United States: Institutional Review Board