Comparison of topical administration and infusion of tranexamic acid on the rate of bleeding in children with non-cyanotic heart disease after open heart surgery

Comparison of topical and continuous infusion of Tranexamic Acid administration on bleeding in pediatric with non-cyanotic congenital heart disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200429047236N1

Enrollment

Registered

2020-05-12

Start date

2019-10-12

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Diseases of Atrial and Ventricular septum defect. Cardiac septal defect, acquired

Interventions

Intervention 1: Intervention group:The first group of interventions includes patients undergoing continuous infusion of 50 mg per kg tranexamic acid from induction to sternum closure. Intervention 2:

Eligibility

Sex/Gender

All

Age

1 Months to 9 Years

Inclusion criteria

Inclusion criteria: Children under 14 kg and over 6 kg For the first time, they undergo cardiac surgery to correct the aforementioned non-cyanotic diseases with cardiac bypass. Clamp aortic time between 60 to 90 minutes CPB(cardio pulmonary bypass) time between 60 to 180 minute Hemoglobin(HB) above 8 mg per deciliter before surgery Minimum age 1 month and maximum age 9 years

Exclusion criteria

Exclusion criteria: hemoglobin below 8 mg per deciliter before surgery Active non-revolutionary disease affecting postoperative recovery such as severe coagulation disorder, hemophilia and.

Design outcomes

Primary

Measure	Time frame
Bleeding rate in children with congenital non-cyanotic heart disease after open heart surgery. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: To determine the amount of bleeding, hemoglobin is measured based on arterial sampling and sent to a laboratory to measure and record arterial blood gases, and the unit is geram per deciliter.	—

Measure

Time frame

Bleeding rate in children with congenital non-cyanotic heart disease after open heart surgery. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: To determine the amount of bleeding, hemoglobin is measured based on arterial sampling and sent to a laboratory to measure and record arterial blood gases, and the unit is geram per deciliter.

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Secondary

Measure	Time frame
Time of intubation. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Hours and minute.;Intensive care unit stay. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Time and minute.;Mount of derenage. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: According to cc.	—

Measure

Time frame

Time of intubation. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Hours and minute.;Intensive care unit stay. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Time and minute.;Mount of derenage. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: According to cc.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMinoo Montazeri

Esfahan University of Medical Sciences

minomah17@yahoo.com+98 21 4481 3915

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026