Effects of Tranexamic Acid on Cytokine Profiles

Effects of Tranexamic Acid on Cytokine Profiles in infants following congenital Cardiac surgery with cardiopulmonary bypass

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016041424538N2

Enrollment

Registered

2016-04-26

Start date

2016-04-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

VSD,TOF,DORV,CAVCD,PS. Q21.0,Q21.3,Q20.1,Q21.2,Q22.1

Interventions

Intervention 1: AMP tranexamic Acid,The TXA dose consist of both an intravenous( After induction of anesthesia ) and pump prime 100 mg/kg. Intervention 2: the saline dose consist of an intravenous(Aft

Treatment - Drugs

Placebo

AMP tranexamic Acid,The TXA dose consist of both an intravenous( After induction of anesthesia ) and pump prime 100 mg/kg

the saline dose consist of an intravenous(After induction of anestesia) and pump prime 1ml/kg.

Eligibility

Sex/Gender

All

Age

6 Months to 5 Years

Inclusion criteria

Inclusion criteria: Entry criteria includ ages from 6 months to 5 years weight from 5 to 15 kg no chronic Coagulopathy no renal dysfunction no TA hypersensibility no chronic hepatopathy no viral and bacterial infection similarity CPB time, cross clamp time and surgery time no previous treatment with immonosupressive agents on 2 weeks before surgery, Exclusion criteria includ no informed consent emergency interventions the preoperative use of mechanical circulatory support at the time of proposed randomization.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Interleukin6. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).;Interleukin8. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).;Interleukin10. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).;TNF alpha. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).	—

Measure

Time frame

Interleukin6. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).;Interleukin8. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).;Interleukin10. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).;TNF alpha. Timepoint: After induction of anesthesia , after declamp and 24 hours after addmission in ICU. Method of measurement: Elisa(pg/ml).

—

Secondary

Measure	Time frame
Mechanical ventilation time. Timepoint: After surgery. Method of measurement: hours.;ICU stay. Timepoint: After surgery. Method of measurement: hours.;Drainage of chest tube. Timepoint: Within 48 hours after surgery. Method of measurement: milliliter.;Tempreture. Timepoint: every 3 hours within 48 hours. Method of measurement: termometere.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmahtab korbi

Shaheed Rajaei Cardiovascular Medical and Research Center

mahtab_korbi@yahoo.com+98 21 23921

Outcome results

None listed

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