NCT00308880

Brief Summary

Tranexamic acid belongs to fibrinolytic inhibitors. Several prospective randomized clinical trials have proved its effectiveness in reducing intra-operative and post-operative bleeding in orthopedic and cardiovascular surgeries. However, there is little study about tranexamic acid in reducing post-operative bleeding in head and neck surgery. So the aim of this study is to investigate if tranexamic acid could reduce post-operative bleeding via prospective double-blinded randomized clinic trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 30, 2006

Status Verified

March 1, 2006

First QC Date

March 29, 2006

Last Update Submit

March 29, 2006

Conditions

Keywords

Tranexamic acidhead neck surgery

Outcome Measures

Primary Outcomes (3)

  • Drainage amount

  • Drainage stay duration

  • Laboratoy data

Interventions

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • head and neck neoplasm scheduled for operation

You may not qualify if:

  • allergy to tranexamic acid
  • history of coagulation disorders
  • under anti-coagulation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Shih-An Liu, MD, MHA

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Cheng Chen, MD

CONTACT

Shih-An Liu, MD, MHA

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 30, 2006

Study Start

March 1, 2006

Study Completion

March 1, 2007

Last Updated

March 30, 2006

Record last verified: 2006-03

Locations