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In endonronchial biopsies there is high risk of bleeding for which prophylactic tranexamic acid is instilled to see for the reduction in bleeding

Role of prophylactic tranexamic Acid instillation in reduction the severity of bleeding during Endobronchial biopsy: a double blind randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095175
Enrollment
100
Registered
2025-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Tranexamic Acid: 500mg(5 ml) of tranexamic acid instilled endobronchial as the lesion is visible Control Intervention1: Placebo: Normal Saline 5 ml endobronchial as soon as the lesion i

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with endobronchial lesion in form of growth, infiltration, nodularity as seen during bronchoscopy

Exclusion criteria

Exclusion criteria: Any contraindication for biopsy that is coagulopathy or hemodynamically unstable condition for bronchoscopy

Design outcomes

Primary

MeasureTime frame
Determine the difference in the proportion of patients with moderate to severe between the intervention and the control arm Timepoint: During procedure

Secondary

MeasureTime frame
Safety End Points: The incidence of thromboembolic events, including myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism.Timepoint: 1 month;Difference in the proportion of patients with each grade of bleeding (1 to 4) as assessed by the bronchoscopist performing the procedure. Timepoint: During procedure;The difference in the duration of the procedure Timepoint: During procedure;Premature interruption of procedureTimepoint: During procedure;Bronchoscopist graded patient s tolerance of the procedure using the VAS scale Timepoint: During procedure

Countries

India

Contacts

Public ContactPratyakcha Rai

AIIMS, Delhi

raipratyakcha26@gmail.com7830653965

Outcome results

None listed

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