Tranexamic Acid in Cyanotic Heart Defects

Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03244423

Enrollment

120

Registered

2017-08-09

Start date

2009-01-31

Completion date

2017-08-31

Last updated

2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Hemorrhage

Keywords

Pediatric, Cyanotic heart disease, Tranexamic acid, Postoperative blood loss

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.

Interventions

DRUGtopical normal saline

2 ml/kg into the pericardial cavity before sternal closure

DRUGNormal saline infusion

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

DRUGIntravenous tranexamic acid

50 mg/kg

DRUGinfusion tranexamic acid

1mg/kg/hr infusionfor 6 hours

DRUGtopical tranexamic acid

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

DRUGNormal saline at induction

0.5 ml/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
total blood transfusion	within the first 24 hours	ml/kg
the interval from protamine to skin closure	within the first 24 hours	the interval from protamine to skin closure
the length of ICU stay	within the first month	by days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026