Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

• Status: Withdrawn
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: rEVO Biologics
• Treatments: Antithrombin III; Antithrombins

Criteria

Inclusion Criteria:

• Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization

• Serum Antithrombin < 60%.

Exclusion Criteria:

• Heart transplantation during ongoing hospitalization

• Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)

• Weight < 40 kg

• Allergy to goat products

• Anticoagulation with a direct thrombin inhibitor

• Religious exception to blood products

• Hypothermia (< 34°C)