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

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530737
• Other study ID #: 1000020202
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2012
• Last updated: January 6, 2015
• Start date: November 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 364 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

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

Other:
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest tube volume loss	Chest tube volume loss (mls/kg) at 24 hours in CCCU	24 hrs post surgery	No
Secondary	Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass	Clinical Outcome Measure	1hr prior to induction of anaestheisa (pre-surgery)	No
Secondary	Blood product transfusions intra-operatively and for the first 24 hours following surgery		24hours post surgery	No
Secondary	Clinical outcomes	(inotropic support, ventilation, CCU stay, hospital stay, thrombosis)	30 days post-surgery	No
Secondary	Intraoperative coagulation profile	(anti-Xa, heparin concentration, activated clotting time, CBC, antithrombin)	5 hours after start of surgery	No
Secondary	Post-operative markers of platelet activation	Post-operative markers of platelet activation (TAT, F1.2), fibrinolysis (d-dimer) and inflammation (CRP)	24 and 72 hrs post surgery	No
Secondary	Use of recombinant factor VIIa after surgery to control post-operative bleeding		48 hrs post surgery	No