Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

Mayo Clinic

Status and phase: Withdrawn; Early Phase 1

Conditions: Antithrombin Deficiency Type 2

Treatments: Drug: ATryn continuous infusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03090893

15-001713

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Infusion group

Experimental group

Description:

Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100

Treatment:

Drug: ATryn continuous infusion