Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

This study has suspended participant recruitment.
(Changes in protocol)
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: December 20, 2013
Last verified: December 2013

February 7, 2012
December 20, 2013
February 2012
February 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01547728 on ClinicalTrials.gov Archive Site
Percentage of cardiopulmonary bypass patients who are heparin resistant [ Time Frame: 5 minutes after intravenous loading dose of heparin, Day 1 of the study ] [ Designated as safety issue: Yes ]
Patient will be identified as heparin resistant according this definition: initial activated clotting time (ACT) after intravenous loading dose of heparin (300 u/kg) is less than 480 seconds. The percentage will be summarized using a point estimate and 95% confidence interval.
Same as current
Not Provided
Not Provided
 
Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery
Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

The objective of this study is to prospectively evaluate the response of recombinant antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to undergo cardiac surgery.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heparin Resistance
Drug: ATryn ® ( recombinant antithrombin, rhAT)
This study evaluates whether ATryn® (recombinant antithrombin,rhAT) will improve heparin responsiveness of heparin resistant patients undergoing cardiopulmonary bypass. This prospective, open label non-randomized study is performed in the operating room. Patients aged 18 to 90 years scheduled for elective cardiopulmonary bypass surgery with a high risk for heparin resistance are approached for participation. Subjects will be enrolled if they exhibit heparin resistance as defined by protocol after an intravenous loading dose of heparin just prior to cardiopulmonary bypass. Enrolled 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.
Other Name: ATryn®
Experimental: ATryn ® (recombinant antithrombin, rhAT)
Assessing the prolongation of the activated clotting time after administration of ATryn® (recombinant antithrombin, rhAT)in heparin resistant patients. Subjects will be enrolled if they exhibit heparin resistance as defined by protocol after an intravenous loading dose of heparin just prior to cardiopulmonary bypass.
Intervention: Drug: ATryn ® ( recombinant antithrombin, rhAT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
February 2015
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB)
  • Heparin resistant according to this definition: initial activated clotting time (ACT) after an intravenous loading dose of heparin (300 u/kg) is less than 480 seconds

Exclusion criteria:

  • current use of one or more of these medications:

    • warfarin (within 3 days of surgery);
    • streptokinase;
    • tissue plasminogen activator;
    • abciximab,
    • eptifibatide,
    • tirofiban or
    • clopidogrel.
  • known hypersensitivity to goat or goat milk proteins,
  • patients with pre-existing coagulopathy defined as a history of bleeding or laboratory bleeding disorder (e.g., von Willebrand disease, platelet disorder) and
  • patients receiving direct thrombin inhibitors
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01547728
11-004125
No
William C. Oliver, Mayo Clinic
Mayo Clinic
rEVO Biologics
Principal Investigator: William Oliver, MD Mayo Clinic
Mayo Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP