Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

NCT01547728 | Terminated Phase 4 Results

• 1 other identifier: 11-004125
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombophilia Due to Acquired Antithrombin III Deficiency

Keywords

antithrombin; Heparin Resistant; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration

  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.

  3 minutes after the initial dose of rhAT, Day 1 of the study

Study Arms (1)

Recombinant antithrombin (rhAT)

EXPERIMENTAL

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.

Drug: Recombinant antithrombin (rhAT)

Interventions

Recombinant antithrombin (rhAT) DRUG

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.

Also known as: ATryn®

Recombinant antithrombin (rhAT)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• rEVO Biologics: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. William Oliver
• Organization: Mayo Clinic Rochester

oliver.william@mayo.edu

507-255-4240

Study Officials

• William Oliver, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consulatant Cardio/Thoracic Anesthesia

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: March 8, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 15, 2015
• Results First Posted: July 15, 2015

Record last verified: 2015-07

Locations

US (1)