Effect of Tranexamic Acid on Prevention of Recurrence of... | NCT01167764

Studies
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

NCT01167764

Sponsor

Seoul National University Hospital

Status

Withdrawn

Last Update Posted

Jan 7, 2014Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Hemoptysis

Interventions

tranexamic acid, placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jul 21, 2010

First Submission Date that Met QC Criteria

Jul 21, 2010

First Posted Date

Jul 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2014

Last Update Posted Date

Jan 7, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tranexamic acid	Active Comparator	tranexamic acid 250mg po 3 times/day for 1 months	Drug: tranexamic acid, placebo
placebo	Placebo Comparator	placebo po 3 times/day for 1 months	Drug: tranexamic acid, placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tranexamic acid, placebo	Drug	tranexamic acid 250mg tid for 1 months vs. placebo for 1 months	placebo tranexamic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the proportion of recurrence of hemoptysis		6 month: 1months medication + 5months observation

Secondary Outcomes

Measure	Description	Time Frame
time to recurrence		6 month: 1months medication + 5months observation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jae-Joon Yim, MD, PhD	Seoul National University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si			South Korea
Seoul National University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006469	Hemoptysis
D012008	Recurrence

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided