Topical and systemic administration of tranexamic acid on pediatric cardiac surgery

A clinical trial comparing the effect of topical and systemic administration of tranexamic acid versus its non-administration on bleeding volume and the need for blood products after cardiac surgery in children with congenital heart disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170316033099N11

Enrollment

120

Registered

2020-02-19

Start date

2019-01-29

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

congenital heart disease. Congenital malformation of heart, unspecified

Interventions

Intervention 1: Intervention group 1 (systemic): After sternotomy, the patient was given 1 milligram per kilogram of tranexamic acid via the cardiopulmonary pump. Subsequently, the patient was prescri

Eligibility

Sex/Gender

All

Age

1 Months to 15 Years

Inclusion criteria

Inclusion criteria: Congenital heart disease Age between one month and 15 years Elective cardiac surgery Surgery performed by one single surgeon Informed consent form signed by the patient's guardian

Exclusion criteria

Exclusion criteria: Treatment with anti-coagulants Presence of hepatic, renal, or respiratory dysfunction Low cardiac output Need for re-surgery Postoperative septicemia

Design outcomes

Primary

Measure	Time frame
Bleeding volume. Timepoint: From the completion of the surgery up to 48 hours after surgery. Method of measurement: Measurement of chest drainage volume in the chest tube.;Need for blood products including packed red blood cells, fresh frozen plasma, and platelets. Timepoint: From the completion of the surgery up to 48 hours after surgery. Method of measurement: Measurement of the packs in terms of cc.	—

Measure

Time frame

Bleeding volume. Timepoint: From the completion of the surgery up to 48 hours after surgery. Method of measurement: Measurement of chest drainage volume in the chest tube.;Need for blood products including packed red blood cells, fresh frozen plasma, and platelets. Timepoint: From the completion of the surgery up to 48 hours after surgery. Method of measurement: Measurement of the packs in terms of cc.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarbod Hatami

Birjand University of Medical Sciences

Farbod_2006_123@yahoo.ca+98 56 3239 5632

Outcome results

None listed

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