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Clinical Safety and Efficacy of Topical Tranexamic Acid

Comparison of Intravenous Vs Topical Tranexamic Acid in patients undergoing Intracardiac Repair for Tetralogy of Fallot: Clinical Efficacy and Safety - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112077
Enrollment
90
Registered
2026-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: Q213- Tetralogy of Fallot

Interventions

Intervention1: Topical Tranexamic Acid: Route Topical (Diluted Tranexamic Acid is instilled into mediastinal cavity). Dose 50mg/kg. Frequency & Duration once before closure. Control Intervention1: Int

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than one year 2. SpO2 less than 80 3. Consecutive patients meeting the above criteria over the 18-month study period.

Exclusion criteria

Exclusion criteria: 1.Emergency surgery 2. Weight less than 6kg 3. Pre-existing renal impairment or Neurologic event (e.g., seizure, stroke, or other neurological deficit) 4. Plt less than 75000 5. INR more than 1.5 6. Allergy to tranexamic acid

Design outcomes

Primary

MeasureTime frame
Postoperative blood loss (cumulative chest-drain output)Timepoint: First 24 hours)

Secondary

MeasureTime frame
1.To compare total blood products transfused within 24 hours after surgery. 2.To assess incidence of re-exploration for bleeding. 3.To evaluate postoperative haemoglobin and haematocrit at Immediate, 6 and 24 hours. 4.To document occurrence of thromboembolic complications and seizures. 5.To compare duration of mechanical ventilation & ICU stay.Timepoint: Till patient is in ICU

Countries

India

Contacts

Public ContactNeeti Makhija

AIIMS, NEW DELHI

NEETIMAKHIJA21@GMAIL.COM9810452292

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026