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

This study has been completed.
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children Identifier:
First received: January 30, 2012
Last updated: January 6, 2015
Last verified: January 2015

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

Condition Intervention Phase
Cardiopulmonary Bypass
Drug: Antithrombin III
Other: Saline Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Brian McCrindle, The Hospital for Sick Children:

Primary Outcome Measures:
  • Chest tube volume loss [ Time Frame: 24 hrs post surgery ]
    Chest tube volume loss (mls/kg) at 24 hours in CCCU

Secondary Outcome Measures:
  • Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass [ Time Frame: 1hr prior to induction of anaestheisa (pre-surgery) ]
    Clinical Outcome Measure

  • Blood product transfusions intra-operatively and for the first 24 hours following surgery [ Time Frame: 24hours post surgery ]
  • Clinical outcomes [ Time Frame: 30 days post-surgery ]
    (inotropic support, ventilation, CCU stay, hospital stay, thrombosis)

  • Intraoperative coagulation profile [ Time Frame: 5 hours after start of surgery ]
    (anti-Xa, heparin concentration, activated clotting time, CBC, antithrombin)

  • Post-operative markers of platelet activation [ Time Frame: 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 [ Time Frame: 48 hrs post surgery ]

Enrollment: 18
Study Start Date: November 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group 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.
Experimental: Active Antithrombin Group Drug: Antithrombin III
Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.


Ages Eligible for Study:   up to 364 Days   (Child)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01530737

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5V1X8
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Brian W McCrindle, MD The Hospital for Sick Children
  More Information

Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children Identifier: NCT01530737     History of Changes
Other Study ID Numbers: 1000020202
Study First Received: January 30, 2012
Last Updated: January 6, 2015

Keywords provided by Brian McCrindle, The Hospital for Sick Children:
anticoagulation efficiency
cardiac surgery

Additional relevant MeSH terms:
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on May 25, 2017