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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01530737
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : January 7, 2015
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children

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

Condition or disease Intervention/treatment Phase
Cardiopulmonary Bypass Drug: Antithrombin III Other: Saline Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
Study Start Date : November 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. 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

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

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

  5. 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)

  6. Use of recombinant factor VIIa after surgery to control post-operative bleeding [ Time Frame: 48 hrs post surgery ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01530737

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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5V1X8
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Brian W McCrindle, MD The Hospital for Sick Children
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Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children Identifier: NCT01530737    
Other Study ID Numbers: 1000020202
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015
Keywords provided by Brian McCrindle, The Hospital for Sick Children:
anticoagulation efficiency
cardiac surgery
Additional relevant MeSH terms:
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Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action