Efficacy of Tranexamic Acid in Hemoptysis

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3

Conditions: Hemoptysis

Treatments: Drug: Tranexamic Acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02781597

HEMOP-TXA 23

Details and patient eligibility

About

The purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding in patients of hemoptysis and also to evaluate the safety of tranexamic acid.

Full description

Hemoptysis is a common problem in India due to high incidence of tuberculosis and also due to post tubercular sequale. Hemoptysis is usually managed conservatively in mild to moderate cases and cases of massive hemoptysis are managed with more definitive treatment options like vessel embolization (bronchial/pulmonary artery) and surgery as a last option. Tranexamic acid is a antifibrinolytic used in many surgeries and trauma patients to control bleeding and it has been shown effective and safe. The purpose of the study is to evaluate the efficacy of tranexamic acid in patients with hemoptysis in controlling bleeding.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Acute ongoing hemoptysis
2. Age: 18 years and above

Exclusion criteria

1. Pregnant females
2. Females on oral contraceptives
3. Patients on antifibrinolytics
4. Patients with known drug allergy
5. Patients with renal failure
6. Patients requiring intubation during study period
7. Patients with Massive hemoptysis (>600 ml/24 hrs)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Tranexamic acid

Active Comparator group

Description:

All patients will receive basic resuscitative measures and standard treatment like assessment and management of Airway, breathing, circulation, antitussives, and blood products. Patients in group T will receive Inj Tranexamic acid in a loading dose of 1 g over 10 min followed by an infusion of 1 g over 8 h.

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

All patients will receive basic resuscitative measures and standard treatment like assessment and management of Airway, breathing, circulation, antitussives, and blood products. Patients will receive 0.9% normal saline instead of Tranexamic acid.

Treatment:

Drug: Placebo