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Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)

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ClinicalTrials.gov Identifier: NCT01698567
Recruitment Status : Terminated (Challenges enrolling subjects in study)
First Posted : October 3, 2012
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Congenital Heart Disease Drug: Antithrombin III Drug: Placebo Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Antithrombin III Supplementation for Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass.
Study Start Date : July 2012
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. p-selectin [ Time Frame: expected average of 24 months ]
  2. interleukin-6 [ Time Frame: Expected average of 24 months ]
  3. prothrombin fragment 1.2 [ Time Frame: expected average of 24 months ]
  4. 24 hour blood loss [ Time Frame: 24 hours post surgery ]
  5. ICU length of stay [ Time Frame: Expected average of 3 days ]
  6. Hospital length of stay [ Time Frame: Expected average of 3 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   up to 180 Days   (Child)
Sexes Eligible for Study:   All
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

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): NCT01698567


Locations
United States, New York
Michael Eaton, MD
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Michael Eaton, MD University of Rochester
More Information

Responsible Party: Michael Eaton, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01698567     History of Changes
Other Study ID Numbers: 38402
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

Keywords provided by Michael Eaton, University of Rochester:
Infants
Cardiopulmonary bypass
anticoaglution

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants