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

Phase 2

• Conditions: Diseases of Atrial and Ventricular septum defect.; Cardiac septal defect, acquired; I51.0

• Registration Number: IRCT20200429047236N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.