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

Phase 3

Completed

• Conditions: Cardiopulmonary Bypass
• Interventions: Other: Saline Placebo; Drug: Antithrombin III

• Registration Number: NCT01530737
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

The primary objective of this study is:

1. 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:

1. 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

2. To determine if a decrease in activation and consumption of coagulation proteins, platelets and subsequent fibrinolysis will result in improved haemostasis following CPB

3. To determine if there will be a reduction in postoperative bleeding and associated clinical complications

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Exclusion Criteria

1. Preoperative antithrombin activity > 85%
2. Prematurity < 36 weeks gestational age at birth
3. 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
4. Any form of coagulopathy or thrombophilic disorder
5. Renal (blood creatinine - estimated GRF < 60ml/min/1.73m2) or clinical liver failure
6. Antithrombin replacement therapy prior to surgery
7. Repeat surgery (including previous ECMO/VAD support as prior surgery)
8. Patients refusal to provide open consent for re-use of study data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Saline Placebo	-
Active Antithrombin Group	Antithrombin III	-

Primary Outcome Measures

Name	Time	Method
Chest tube volume loss	24 hrs post surgery	Chest tube volume loss (mls/kg) at 24 hours in CCCU

Secondary Outcome Measures

Name	Time	Method
Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass	1hr prior to induction of anaestheisa (pre-surgery)	Clinical Outcome Measure
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	(anti-Xa, heparin concentration, activated clotting time, CBC, antithrombin)
Post-operative markers of platelet activation	24 and 72 hrs post surgery	Post-operative markers of platelet activation (TAT, F1.2), fibrinolysis (d-dimer) and inflammation (CRP)
Clinical outcomes	30 days post-surgery	(inotropic support, ventilation, CCU stay, hospital stay, thrombosis)
Use of recombinant factor VIIa after surgery to control post-operative bleeding	48 hrs post surgery

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada