Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03090893

Enrollment

Registered

2017-03-27

Start date

2018-06-01

Completion date

2019-06-30

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antithrombin Deficiency Type 2

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.

Interventions

DRUGATryn continuous infusion

replenish serum thrombin levels

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of time within the serum AT level target range of 80-100%	72 hour infusion period	Target value of Antithrombin is recorded as %

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026