Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery
This study has suspended participant recruitment.
(Changes in protocol)
Sponsor:
Mayo Clinic
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heparin Resistance |
Drug: ATryn ® ( recombinant antithrombin, rhAT) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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®
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547728
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
GTC Biotherapeutics
Investigators
| Principal Investigator: | William Oliver, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | William C. Oliver, Consulatant Cardio/Thoracic Anesthesia, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01547728 History of Changes |
| Other Study ID Numbers: | 11-004125 |
| Study First Received: | February 7, 2012 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
antithrombin Heparin Resistant Cardiac Surgery |
Additional relevant MeSH terms:
|
Antithrombins Antithrombin III Antithrombin Proteins Calcium heparin Heparin Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anticoagulants Hematologic Agents Therapeutic Uses Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013