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Trial record 5 of 9 for:    "Hereditary Antithrombin Deficiency" | "HIV Protease Inhibitors"

Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01547728
Recruitment Status : Terminated (Too many barriers to enroll participants.)
First Posted : March 8, 2012
Results First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
rEVO Biologics
Information provided by (Responsible Party):
William C. Oliver, Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Thrombophilia Due to Acquired Antithrombin III Deficiency
Intervention Drug: Recombinant antithrombin (rhAT)
Enrollment 42
Recruitment Details Subjects were recruited from Mayo Clinic in Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Recombinant Antithrombin (rhAT)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 42
Completed 1
Not Completed 41
Reason Not Completed
Change in procedure and equipment             1
Drug not ready for subject             1
Screen failure             39
Arm/Group Title Recombinant Antithrombin (rhAT)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
64
(19 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
15
  35.7%
Male
27
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
1.Primary Outcome
Title Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration
Hide Description Restored antithrombin level is defined as an activated clotting time > 480 seconds 3 minutes after the initial dose of 500 units of rhAT is administered. The percentage of patients who meet this criterion will be summarized using a point estimate and a 95% confidence interval.
Time Frame 3 minutes after the initial dose of rhAT, Day 1 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because there were too many barriers to enroll participants.
Arm/Group Title Recombinant Antithrombin (rhAT)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Recombinant Antithrombin (rhAT)
Hide Arm/Group Description 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.
All-Cause Mortality
Recombinant Antithrombin (rhAT)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Recombinant Antithrombin (rhAT)
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Recombinant Antithrombin (rhAT)
Affected / at Risk (%)
Total   0/1 (0.00%) 
The study was terminated because there were too many barriers to enroll participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. William Oliver
Organization: Mayo Clinic Rochester
Phone: 507-255-4240
EMail: oliver.william@mayo.edu
Layout table for additonal information
Responsible Party: William C. Oliver, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01547728     History of Changes
Other Study ID Numbers: 11-004125
First Submitted: February 7, 2012
First Posted: March 8, 2012
Results First Submitted: April 21, 2015
Results First Posted: July 15, 2015
Last Update Posted: July 15, 2015