Efficacy of Tranexamic Acid in Hemoptysis

Efficacy of Tranexamic Acid in Controlling Hemoptysis, A Randomized Control Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02781597

Enrollment

Registered

2016-05-24

Start date

2011-01-31

Completion date

2012-06-30

Last updated

2016-05-24

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

Conditions

Hemoptysis

Keywords

Hemoptysis, Tranexamic acid, VAS score

Brief summary

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.

Detailed 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.

Interventions

DRUGTranexamic Acid

Patients will receive Inj Tranexamic acid, in IV in a loading dose of 1 g over 10 min followed by an infusion of 1 g over 8 h in 500ml normal saline

DRUGPlacebo

Patients will receive 0.9% normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Change in severity of hemoptysis	day1 and day2	Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.

Secondary

Measure	Time frame	Description
Intervention needed	2 days	Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No)
Blood transfusion needed	2 days	Number of blood transfused
Hospital stay	Through study completion, an average of 1 year	Number of days of hospital stay

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026