Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

Sponsor

Seoul National University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01167764

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.

Condition or Disease	Intervention/Treatment	Phase
Hemoptysis	Drug: tranexamic acid, placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tranexamic acid tranexamic acid 250mg po 3 times/day for 1 months	Drug: tranexamic acid, placebo tranexamic acid 250mg tid for 1 months vs. placebo for 1 months
Placebo Comparator: placebo placebo po 3 times/day for 1 months	Drug: tranexamic acid, placebo tranexamic acid 250mg tid for 1 months vs. placebo for 1 months

Arm

Intervention/Treatment

Active Comparator: tranexamic acid

tranexamic acid 250mg po 3 times/day for 1 months

Drug: tranexamic acid, placebo

tranexamic acid 250mg tid for 1 months vs. placebo for 1 months

Placebo Comparator: placebo

placebo po 3 times/day for 1 months

Drug: tranexamic acid, placebo

tranexamic acid 250mg tid for 1 months vs. placebo for 1 months

Outcome Measures

Primary Outcome Measures

the proportion of recurrence of hemoptysis [6 month: 1months medication + 5months observation]

Secondary Outcome Measures

time to recurrence [6 month: 1months medication + 5months observation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age: >=20 and <=75
ER visit or admission for hemoptysis
no evidence of hemoptysis on screening

Exclusion Criteria:

anticoagulation treatment
Cr >= 2.0 mg/dL or urinary protein >= 2+ or who received renal replacement treatment
hepatic failure: total bilirubin >= 1.5 mg/dL or AST or ALT >= 1.5 of upper normal limit level
hypersensitivity to tranexamic acid
pregnant woman
fertile female who don't use contraception

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Korea, Republic of
2	Seoul National University Hospital	Seoul	Korea, Republic of	110-744
3	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul	Korea, Republic of