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

Duke University

Status and phase

Completed

Phase 2

Conditions

ATIII Deficiency

Treatments

Other: Placebo

Drug: Anti-thrombin III

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02103114

Pro00051186

Details and patient eligibility

About

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.

Full description

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

Enrollment

45 patients

Sex

All

Ages

Under 7 months old

Volunteers

No Healthy Volunteers

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