Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03090893
Recruitment Status : Withdrawn (PI passed away)
First Posted : March 27, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
rEVO Biologics
Information provided by (Responsible Party):
William C. Oliver, 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.

Condition or disease Intervention/treatment Phase
Antithrombin Deficiency Type 2 Drug: ATryn continuous infusion Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Infusion group
Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100
Drug: ATryn continuous infusion
replenish serum thrombin levels




Primary Outcome Measures :
  1. Percentage of time within the serum AT level target range of 80-100% [ Time Frame: 72 hour infusion period ]
    Target value of Antithrombin is recorded as %



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090893


Sponsors and Collaborators
Mayo Clinic
rEVO Biologics
Investigators
Layout table for investigator information
Principal Investigator: William C. Oliver, Jr., MD Mayo Clinic

Layout table for additonal information
Responsible Party: William C. Oliver, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03090893     History of Changes
Other Study ID Numbers: 15-001713
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: will not share individual patient data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Antithrombin III Deficiency
Thrombophilia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Genetic Diseases, Inborn
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants