Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

Early Phase 1WithdrawnNCT03090893

Mayo Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Antithrombin Deficiency Type 2

Interventions

ATryn continuous infusionDRUG

replenish serum thrombin levels

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percentage of time within the serum AT level target range of 80-100%

Target value of Antithrombin is recorded as %

Time frame: 72 hour infusion period

Data from ClinicalTrials.gov

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