Cardiopulmonary Bypass
Conditions
Keywords
pediatric, Antithrombin, anticoagulation efficiency, cardiac surgery
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
Interventions
DRUGAntithrombin III
Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.
OTHERSaline 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 364 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chest tube volume loss | 24 hrs post surgery | Chest tube volume loss (mls/kg) at 24 hours in CCCU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood product transfusions intra-operatively and for the first 24 hours following surgery | 24hours post surgery | — |
| Clinical outcomes | 30 days post-surgery | (inotropic support, ventilation, CCU stay, hospital stay, thrombosis) |
| 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 |
| 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) |
| Use of recombinant factor VIIa after surgery to control post-operative bleeding | 48 hrs post surgery | — |
| Intraoperative coagulation profile | 5 hours after start of surgery | (anti-Xa, heparin concentration, activated clotting time, CBC, antithrombin) |
Countries
Canada
Outcome results
None listed