Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
Early Phase 1
Withdrawn
- Conditions
- Antithrombin Deficiency Type 2
- Interventions
- Registration Number
- NCT03090893
- Lead Sponsor
- Mayo Clinic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Infusion group ATryn continuous infusion Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100
- Primary Outcome Measures
Name Time Method Percentage of time within the serum AT level target range of 80-100% 72 hour infusion period Target value of Antithrombin is recorded as %
- Secondary Outcome Measures
Name Time Method