Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery

The Hospital for Sick Children1 site in 1 country18 target enrollmentNovember 2011

ConditionsCardiopulmonary Bypass

InterventionsSaline Placebo Antithrombin III

DrugsAntithrombin III

Overview

Phase: Phase 3
Intervention: Saline Placebo
Conditions: Cardiopulmonary Bypass
Sponsor: The Hospital for Sick Children
Enrollment: 18
Locations: 1
Primary Endpoint: Chest tube volume loss
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is:

To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age undergoing cardiopulmonary bypass (CPB) for cardiac surgery

The secondary objectives of this study are:

To determine if the administration of AT concentrate prior to heparinization will decrease the amount of heparin required to achieve optimal anticoagulation (as defined by anti-Xa levels) during CPB
To determine if a decrease in activation and consumption of coagulation proteins, platelets and subsequent fibrinolysis will result in improved haemostasis following CPB
To determine if there will be a reduction in postoperative bleeding and associated clinical complications

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Hospital for Sick Children

Responsible Party

Principal Investigator

Brian McCrindle

Staff Cardiologist

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

•Pediatric patients \< 1 year old with cardiac defect (acquired or congenital) requiring cardiac surgery
•Planned cardiac surgery with cardiopulmonary bypass
•Weight \> 2.5kg at the time of surgery
•Enrolment in the CATCH main study (REB#1000020203)

Exclusion Criteria

•Preoperative antithrombin activity \> 85%
•Prematurity \< 36 weeks gestational age at birth
•Preoperative use of systemic anticoagulant (i.e. heparin or warfarin at a therapeutic dose) for \> 24 hours or at any time within the 48 hours prior to surgery
•Any form of coagulopathy or thrombophilic disorder
•Renal (blood creatinine - estimated GRF \< 60ml/min/1.73m2) or clinical liver failure
•Antithrombin replacement therapy prior to surgery
•Repeat surgery (including previous ECMO/VAD support as prior surgery)
•Patients refusal to provide open consent for re-use of study data

Arms & Interventions

Control Group

Intervention: Saline Placebo

Active Antithrombin Group

Intervention: Antithrombin III

Outcomes

Primary Outcomes

Chest tube volume loss

Time Frame: 24 hrs post surgery

Chest tube volume loss (mls/kg) at 24 hours in CCCU

Secondary Outcomes

Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass(1hr prior to induction of anaestheisa (pre-surgery))
Blood product transfusions intra-operatively and for the first 24 hours following surgery(24hours post surgery)
Intraoperative coagulation profile(5 hours after start of surgery)
Post-operative markers of platelet activation(24 and 72 hrs post surgery)
Clinical outcomes(30 days post-surgery)
Use of recombinant factor VIIa after surgery to control post-operative bleeding(48 hrs post surgery)