Back to resultsResponse of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
Primary Purpose
Antithrombin Deficiency Type 2
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
ATryn continuous infusion
Sponsored by
About this trial
This is an interventional supportive care trial for Antithrombin Deficiency Type 2
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infusion group
Arm Description
Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100
Outcomes
Primary Outcome Measures
Percentage of time within the serum AT level target range of 80-100%
Target value of Antithrombin is recorded as %
Secondary Outcome Measures
Full Information
NCT ID
NCT03090893
First Posted
March 21, 2017
Last Updated
September 6, 2018
Sponsor
Mayo Clinic
Collaborators
rEVO Biologics
1. Study Identification
Unique Protocol Identification Number
NCT03090893
Brief Title
Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI passed away
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
rEVO Biologics
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antithrombin Deficiency Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infusion group
Arm Type
Experimental
Arm Description
Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100
Intervention Type
Drug
Intervention Name(s)
ATryn continuous infusion
Intervention Description
replenish serum thrombin levels
Primary Outcome Measure Information:
Title
Percentage of time within the serum AT level target range of 80-100%
Description
Target value of Antithrombin is recorded as %
Time Frame
72 hour infusion period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C. Oliver, Jr., MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
will not share individual patient data
Learn more about this trial
Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
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