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Completed

NCT Number: NCT01530737

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

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

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Key information

Conditions

Cardiopulmonary Bypass

Age range

Up to 364 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients < 1 year old with cardiac defect (acquired or congenital) requiring cardiac surgery
  • Planned cardiac surgery with cardiopulmonary bypass
  • Weight > 2.5kg at the time of surgery
  • Enrolment in the CATCH main study (REB#1000020203)

Exclusion criteria

  • Preoperative antithrombin activity > 85%
  • Prematurity < 36 weeks gestational age at birth
  • 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
  • Any form of coagulopathy or thrombophilic disorder
  • Renal (blood creatinine - estimated GRF < 60ml/min/1.73m2) or clinical liver failure
  • Antithrombin replacement therapy prior to surgery
  • Repeat surgery (including previous ECMO/VAD support as prior surgery)
  • Patients refusal to provide open consent for re-use of study data

Treatment and study plan

Antithrombin III

Drug

Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.

Saline Placebo

Other

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.

Primary outcomes

  1. Chest tube volume loss

    Time frame: 24 hrs post surgery

    Chest tube volume loss (mls/kg) at 24 hours in CCCU

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2012
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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