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

NCT ID: NCT01530737

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-10-31

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

Conditions

Cardiopulmonary Bypass

Study Design

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

Study Groups

Control Group

Group Type: PLACEBO_COMPARATOR

Saline Placebo

Intervention Type: OTHER

Patients randomized to the control group will receive a placebo consisting of normal saline in a volume equivalent to the volume of antithrombin the same patient in the treatment group would have received and administered by anesthesia and perfusion in the exact same manner as the AT is administered in the treatment group.

Active Antithrombin Group

Group Type: EXPERIMENTAL

Antithrombin III

Intervention Type: DRUG

Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.

Interventions

Antithrombin III

Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.

Intervention Type: DRUG

Saline Placebo

Patients randomized to the control group will receive a placebo consisting of normal saline in a volume equivalent to the volume of antithrombin the same patient in the treatment group would have received and administered by anesthesia and perfusion in the exact same manner as the AT is administered in the treatment group.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 364 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Brian McCrindle

Staff Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian W McCrindle, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000020202

Identifier Type: -

Identifier Source: org_study_id