Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

This study has suspended participant recruitment.

(Changes in protocol)

Sponsor:

Collaborator:

GTC Biotherapeutics

Information provided by (Responsible Party):

William C. Oliver, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01547728

First received: February 7, 2012

Last updated: April 29, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2012

Last Updated Date

April 29, 2013

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01547728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

Official Title ^ICMJE

Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heparin Resistance

Intervention ^ICMJE

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®

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01547728

Other Study ID Numbers ^ICMJE

11-004125

Has Data Monitoring Committee

Responsible Party

William C. Oliver, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

GTC Biotherapeutics

Investigators ^ICMJE

Principal Investigator:

William Oliver, MD

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

April 2013

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

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