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

This study is currently recruiting participants.
Verified February 2012 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01530737
First received: January 30, 2012
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Chest tube volume loss [ Time Frame: 24 hrs post surgery ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Clinical Outcome Measure

  • Blood product transfusions intra-operatively and for the first 24 hours following surgery [ Time Frame: 24hours post surgery ] [ Designated as safety issue: No ]
  • Clinical outcomes [ Time Frame: 30 days post-surgery ] [ Designated as safety issue: No ]
    (inotropic support, ventilation, CCU stay, hospital stay, thrombosis)

  • Intraoperative coagulation profile [ Time Frame: 5 hours after start of surgery ] [ Designated as safety issue: No ]
    (anti-Xa, heparin concentration, activated clotting time, CBC, antithrombin)

  • Post-operative markers of platelet activation [ Time Frame: 24 and 72 hrs post surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 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.

  Eligibility

Ages Eligible for Study:   up to 364 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530737

Contacts
Contact: Cedric Manlhiot 416-813-7617 cedric.manlhiot@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Principal Investigator: Brian W McCrindle, MD            
Sub-Investigator: Colleen E Gruenwald, MD            
Sub-Investigator: Cedric Manlhiot            
Sub-Investigator: Leonardo R Brandao, MD            
Sub-Investigator: Luc Mertens, MD            
Sub-Investigator: Seema Mital, MD            
Sub-Investigator: Leland N Benson, MD            
Sub-Investigator: Christopher A Caldarone, MD            
Sub-Investigator: Helen M Holtby, MD            
Sub-Investigator: Jennifer L Russell, MD            
Sub-Investigator: Steven M Schwartz, MD            
Sub-Investigator: Ben V Sivarajan, MD            
Sub-Investigator: Glen Van Arsdell, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Brian W McCrindle, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01530737     History of Changes
Other Study ID Numbers: 1000020202
Study First Received: January 30, 2012
Last Updated: February 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatric
Antithrombin
anticoagulation efficiency
cardiac surgery

Additional relevant MeSH terms:
Antithrombins
Antithrombin III
Antithrombin Proteins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013