The Role of Tranexamic Acid in Reducing Blood Transfusion... | NCT01914211

Studies
The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates

NCT01914211

Sponsor

Aymen N Naguib

Status

Withdrawn

Last Update Posted

Feb 1, 2017Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Tranexamic Acid
Acute Normovolemic Hemodilution

Countries

United States

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 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jul 31, 2013

First Submission Date that Met QC Criteria

Jul 31, 2013

First Posted Date

Aug 2, 2013Estimated

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 31, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Aymen N NaguibOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute Normovolemic Hemodilution		Patients that receive acute normovolemic hemodilution prior to surgery.	Procedure: Acute Normovolemic Hemodilution
Tranexamic Acid		Patients that receive tranexamic acid during surgery.	Drug: Tranexamic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic Acid	Drug	100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.	Tranexamic Acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of postoperative hemostasis	Evaluating the body's ability to stop or decrease postoperative bleeding.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Volume of blood transfusions	Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op.	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).

Exclusion Criteria:

Jehovah's witness patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

28 Days

Standard Ages

Child

Study Population

Patients from the cardiothoracic surgery population at Nationwide Children's Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided