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Completed

NCT Number: NCT03244423

Tranexamic Acid in Cyanotic Heart Defects

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

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Key information

Conditions

Postoperative Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, 74111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normal saline at induction

Drug

0.5 ml/kg

Normal saline infusion

Drug

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

Intravenous tranexamic acid

Drug

50 mg/kg

infusion tranexamic acid

Drug

1mg/kg/hr infusionfor 6 hours

Topical tranexamic acid

Drug

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

topical normal saline

Drug

2 ml/kg into the pericardial cavity before sternal closure

Primary outcomes

  1. postoperative blood loss

    Time frame: within the first 24 hours

    Blood loss will be measured within first 24 hr.

Secondary outcomes

  1. total blood transfusion

    Time frame: within the first 24 hours

    ml/kg

  2. the interval from protamine to skin closure

    Time frame: within the first 24 hours

    the interval from protamine to skin closure

  3. the length of ICU stay

    Time frame: within the first month

    by days

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2017
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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