Tranexamic Acid in Cyanotic Heart Defects | NCT03244423

Studies
Tranexamic Acid in Cyanotic Heart Defects

NCT03244423

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jan 31, 2018Actual

Enrollment

120Actual

Phase

Phase 2

Conditions

Postoperative Hemorrhage

Interventions

Normal saline at induction
Normal saline infusion
Intravenous tranexamic acid
infusion tranexamic acid
topical tranexamic acid
topical normal saline

Countries

Egypt

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 2018

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

Jan 2009Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Aug 7, 2017

First Submission Date that Met QC Criteria

Aug 7, 2017

First Posted Date

Aug 9, 2017Actual

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 30, 2018

Last Update Posted Date

Jan 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sayed Kaoud Abd-Elshafy, Associate Profossor of Anesthesiology, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies

Detailed Description

40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Placebo Comparator	In control group will receive normal saline,	Drug: Normal saline at induction Drug: Normal saline infusion Drug: topical normal saline
Group 2	Active Comparator	Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours	Drug: Intravenous tranexamic acid Drug: infusion tranexamic acid Drug: topical normal saline
Group 3	Active Comparator	the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.	Drug: Normal saline at induction Drug: Normal saline infusion Drug: topical tranexamic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Normal saline at induction	Drug	0.5 ml/kg	Group 1 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative blood loss	Blood loss will be measured within first 24 hr.	within the first 24 hours

Secondary Outcomes

Measure	Description	Time Frame
total blood transfusion	ml/kg	within the first 24 hours
the interval from protamine to skin closure	the interval from protamine to skin closure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass

Exclusion Criteria:

Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sayed k Abd-Elshafy, MD	Associate profossor of anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Asyut		74111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

UNDECIDED

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019106	Postoperative Hemorrhage

Ancestor Terms

ID	Term
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid
D000077330	Saline Solution

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided