Antithrombin Deficiency Type 2 Clinical Trial
Official title:
A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients
| Verified date | September 2018 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | rEVO Biologics |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of time within the serum AT level target range of 80-100% | Target value of Antithrombin is recorded as % | 72 hour infusion period |