NCT03244423

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

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

January 1, 2009

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

8.6 years

First QC Date

August 7, 2017

Last Update Submit

January 30, 2018

Conditions

Postoperative Hemorrhage

Keywords

PediatricCyanotic heart diseaseTranexamic acidPostoperative blood loss

Outcome Measures

Primary Outcomes (1)

  • postoperative blood loss

    Blood loss will be measured within first 24 hr.

    within the first 24 hours

Secondary Outcomes (3)

  • total blood transfusion

    within the first 24 hours

  • the interval from protamine to skin closure

    within the first 24 hours

  • the length of ICU stay

    within the first month

Study Arms (3)

Group 1

PLACEBO COMPARATOR

In control group will receive normal saline,

Drug: Normal saline at inductionDrug: Normal saline infusionDrug: 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 acidDrug: infusion tranexamic acidDrug: 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 inductionDrug: Normal saline infusionDrug: topical tranexamic acid

Interventions

Normal saline at inductionDRUG

0.5 ml/kg

Group 1Group 3
Normal saline infusionDRUG

1ml/kg/hr. during surgery for six hours

Group 1Group 3
Intravenous tranexamic acidDRUG

50 mg/kg

Group 2
infusion tranexamic acidDRUG

1mg/kg/hr infusionfor 6 hours

Group 2
topical tranexamic acidDRUG

50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure

Group 3
topical normal salineDRUG

2 ml/kg into the pericardial cavity before sternal closure

Group 1Group 2

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 12 years cyanotic cardiac disease with cardio pulmonary bypass

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 74111, Egypt

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sayed k Abd-Elshafy, MD

    Associate profossor of anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profossor of Anesthesiology

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 9, 2017

Study Start

January 1, 2009

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

EG(1)