Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

NCT03090893 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 15-001713
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antithrombin Deficiency Type 2

Outcome Measures

Primary Outcomes (1)

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

  Target value of Antithrombin is recorded as %

  72 hour infusion period

Study Arms (1)

Infusion group

EXPERIMENTAL

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

Drug: ATryn continuous infusion

Interventions

ATryn continuous infusion DRUG

replenish serum thrombin levels

Infusion group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• rEVO Biologics: collaborator

MeSH Terms

Conditions

Antithrombin deficiency type 2

Study Officials

• William C. Oliver, Jr., MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share