Antithrombin Enhancement May Improve Anticoagulation Effi... | NCT01530737

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

NCT01530737

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Jan 7, 2015Estimated

Enrollment

18Actual

Phase

Phase 3

Conditions

Cardiopulmonary Bypass

Interventions

Antithrombin III
Saline Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 30, 2012

First Submission Date that Met QC Criteria

Feb 7, 2012

First Posted Date

Feb 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2015

Last Update Posted Date

Jan 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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
To determine if a decrease in activation and consumption of coagulation proteins, platelets and subsequent fibrinolysis will result in improved haemostasis following CPB
To determine if there will be a reduction in postoperative bleeding and associated clinical complications

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	Placebo Comparator		Other: Saline Placebo
Active Antithrombin Group	Experimental		Drug: Antithrombin III

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antithrombin III	Drug	Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.	Active Antithrombin Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chest tube volume loss	Chest tube volume loss (mls/kg) at 24 hours in CCCU	24 hrs post surgery

Secondary Outcomes

Measure	Description	Time Frame
Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass	Clinical Outcome Measure	1hr prior to induction of anaestheisa (pre-surgery)
Blood product transfusions intra-operatively and for the first 24 hours following surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

364 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian W McCrindle, MD	The Hospital for Sick Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5V1X8	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D000990	Antithrombin III

Ancestor Terms

ID	Term
D058833	Antithrombin Proteins
D015843	Serpins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

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