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Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)

This study is currently recruiting participants.
Verified October 2012 by University of Rochester
Sponsor:
Collaborator:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Michael Eaton, University of Rochester
ClinicalTrials.gov Identifier:
NCT01698567
First received: September 4, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.


Condition Intervention Phase
Congenital Heart Disease
 Drug: Antithrombin III
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Antithrombin III Supplementation for Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • The primary hypothesis is that treatment with ATIII before bypass will decrease the activation of inflammation during CPB as measured by plasma neutrophil elastase. [ Time Frame: Expected average of 24 months ] [ Designated as safety issue: Yes ]
    Patients treated with ATIII as standard of care (good clinical practice) will remain in the study and be analyzed by their intention to treat group. Review of our clinical experience shows that treatment with ATIII for heparin resistance occurs in 2-3% of cases. If there are more than two patients so treated, we will also perform an "as-treated" analysis.


Secondary Outcome Measures:
  • p-selectin [ Time Frame: expected average of 24 months ] [ Designated as safety issue: Yes ]
  • interleukin-6 [ Time Frame: Expected average of 24 months ] [ Designated as safety issue: Yes ]
  • prothrombin fragment 1.2 [ Time Frame: expected average of 24 months ] [ Designated as safety issue: Yes ]
  • 24 hour blood loss [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: Expected average of 3 days ] [ Designated as safety issue: Yes ]
  • Hospital length of stay [ Time Frame: Expected average of 3 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antithrombin III

Product- Antithrombin III is derived from pooled human plasma

ATIII will be dosed using the formula recommended by the manufacturer:

(goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity [7], goal 120% activity[18], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)

a.

 Drug: Placebo
placebo (normal saline) after induction of anesthesia and before commencement of bypass. ATIII will be dosed using the formula recommended by the manufacturer: (goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity [7], goal 120% activity[18], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)
Other Name: Normal Saline
Placebo Comparator: Placebo
placebo (normal saline)
 Drug: Antithrombin III

ATIII will be dosed using the formula recommended by the manufacturer:

(goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity [7], goal 120% activity[18], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)

Other Name: Thrombate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 180 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be included if they are presenting for elective cardiac surgery using cardiopulmonary bypass and are 180 days of age or less.

Exclusion Criteria:

Sensitivity to ATIII product (Thrombate, Grifols, Los Angeles, CA)

  • Known inherited or acquired coagulation defect
  • Current or prior treatment with pro-or anticoagulant medication within past 30 days (except aspirin or a single dose of heparin, e.g. for catheterization)
  • Known central venous thrombosis
  • Recent (30 days) transfusion with hemostatic blood products (fresh-frozen plasma, platelets, cryoprecipitate, whole blood)
  • wt less than 3000g
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698567

Contacts
Contact: Michael Eaton, MD 585-275-2141 Michael_eaton@urmc.rochester.edu
Contact: Suzanne Donahue, RN 585-275-1650 suzanne_donahue@urmc.rochester.edu

Locations
United States, New York
Michael Eaton, MD Recruiting
Rochester, New York, United States, 14642
Contact: Suzanne Donahue, RN     585-275-1650     suzanne_donahue@urmc.rochester.edu    
Contact: Tammy Ortiz     585-273-2972     tammy_ortiz@urmc.rochester.edu    
Sponsors and Collaborators
University of Rochester
Grifols Therapeutics Inc.
Investigators
Principal Investigator: Michael Eaton, MD University of Rochester
  More Information

No publications provided

Responsible Party: Michael Eaton, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01698567     History of Changes
Other Study ID Numbers: 38402
Study First Received: September 4, 2012
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Infants
Cardiopulmonary bypass
anticoaglution

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Antithrombins
Antithrombin III
Antithrombin Proteins
 Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013