Clinical trial NCT01530737: Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
Official title: Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiopulmonary Bypass
Keywords: pediatric
Antithrombin
anticoagulation efficiency
cardiac surgery
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 18
Sex: ALL
Maximum age (years): 364
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Chest tube volume loss
timeFrame: 24 hrs post surgery
Secondary outcomes:
measure: Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass
timeFrame: 1hr prior to induction of anaestheisa (pre-surgery)
measure: Blood product transfusions intra-operatively and for the first 24 hours following surgery
timeFrame: 24hours post surgery
measure: Clinical outcomes
timeFrame: 30 days post-surgery
measure: Intraoperative coagulation profile
timeFrame: 5 hours after start of surgery
measure: Post-operative markers of platelet activation
timeFrame: 24 and 72 hrs post surgery
measure: Use of recombinant factor VIIa after surgery to control post-operative bleeding
timeFrame: 48 hrs post surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Brian W McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
References: