Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery

NCT ID: NCT02103114

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-07-01

Brief Summary

The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. The investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the ICU period.

Detailed Description

If Preoperative ATIII functional assay level is less than 70% patients would be enrolled and randomized to either Placebo (normal saline) or ATIII.

Conditions

ATIII Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Anti-thrombin III

Group Type: EXPERIMENTAL

Anti-thrombin III

Intervention Type: DRUG

Intraoperatively- (correcting to 100%) according to the following formula:

Units required = ((100%- baseline ATIII level*%) X body weight)/1.4

• expressed as a % normal level based on functional ATIII assay

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Normal saline placebo

Interventions

Anti-thrombin III

Intraoperatively- (correcting to 100%) according to the following formula:

Units required = ((100%- baseline ATIII level*%) X body weight)/1.4

• expressed as a % normal level based on functional ATIII assay

Intervention Type: DRUG

Placebo

Normal saline placebo

Intervention Type: OTHER

Other Intervention Names

Thrombate III

Eligibility Criteria

Inclusion Criteria

• All patients less than 7 months of age going for cardiac surgery that will require cardiopulmonary bypass (CPB) with a documented ATIII level below 70%

Exclusion Criteria

• Less than 2.5kg
• Known or suspected hereditary ATIII deficiency (family history of venous thrombosis with decreased plasma levels of ATIII and no other potential causes of acquired decreased ATIII)
• On Ecmo (extracorporeal membrane oxygenation ) at time of surgery
• Known history of thrombosis
• Renal failure as described by the pediatric RIFLE criteria
• H/o intracranial hemorrhage
• Prematurity less than 37 weeks estimated gestational age
• Previously diagnosed pro-thrombotic or hemorrhagic disorder
• Prior ATIII supplementation
• Prior therapeutic anticoagulant use

• Maximum Eligible Age: 7 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Biologicals, LLC

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edmund Jooste, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00051186

Identifier Type: -

Identifier Source: org_study_id