Tranexamic Acid in Cyanotic Heart Defects

Assiut University

Status and phase: Completed; Phase 2

Conditions: Postoperative Hemorrhage

Treatments: Drug: infusion tranexamic acid; Drug: Intravenous tranexamic acid; Drug: topical tranexamic acid; Drug: Normal saline at induction; Drug: Normal saline infusion; Drug: topical normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03244423

IRB0000879560

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

In control group will receive normal saline,

Treatment:

Drug: Normal saline infusion

Drug: topical normal saline

Drug: Normal saline at induction

Group 2

Active Comparator group

Description:

Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours

Treatment:

Drug: infusion tranexamic acid

Drug: Intravenous tranexamic acid

Drug: topical normal saline

Group 3

Active Comparator group

Description:

the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.

Treatment:

Drug: topical tranexamic acid

Drug: Normal saline infusion

Drug: Normal saline at induction