NCT01530737

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. 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. 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. 3.To determine if there will be a reduction in postoperative bleeding and associated clinical complications

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

January 30, 2012

Last Update Submit

January 6, 2015

Conditions

Cardiopulmonary Bypass

Keywords

pediatricAntithrombinanticoagulation efficiencycardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Chest tube volume loss

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

    24 hrs post surgery

Secondary Outcomes (6)

  • Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass

    1hr prior to induction of anaestheisa (pre-surgery)

  • Blood product transfusions intra-operatively and for the first 24 hours following surgery

    24hours post surgery

  • Clinical outcomes

    30 days post-surgery

  • Intraoperative coagulation profile

    5 hours after start of surgery

  • Post-operative markers of platelet activation

    24 and 72 hrs post surgery

  • +1 more secondary outcomes

Study Arms (2)

Control Group

PLACEBO COMPARATOR
Other: Saline Placebo

Active Antithrombin Group

EXPERIMENTAL
Drug: Antithrombin III

Interventions

Antithrombin IIIDRUG

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

Active Antithrombin Group
Saline PlaceboOTHER

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.

Control Group

Eligibility Criteria

AgeUp to 364 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

MeSH Terms

Interventions

Antithrombin III

Intervention Hierarchy (Ancestors)

Antithrombin ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsAlpha-GlobulinsSerum GlobulinsBlood ProteinsProteinsGlobulinsBlood Coagulation Factor InhibitorsBiological Factors

Study Officials

  • Brian W McCrindle, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Cardiologist

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 10, 2012

Study Start

November 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

CA(1)