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Tranexamic Acid and Head and Neck Surgery Patients

Primary Purpose

Head and Neck Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Transamin
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Tranexamic acid, head neck surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: head and neck neoplasm scheduled for operation Exclusion Criteria: allergy to tranexamic acid history of coagulation disorders under anti-coagulation therapy

Sites / Locations

  • Taichung Veterans General HospitalRecruiting

Outcomes

Primary Outcome Measures

Drainage amount
Drainage stay duration
Laboratoy data

Secondary Outcome Measures

Full Information

First Posted
March 29, 2006
Last Updated
March 29, 2006
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00308880
Brief Title
Tranexamic Acid and Head and Neck Surgery Patients
Official Title
If Tranexamic Acid Could Reduce the Duration of Drainage Tube Placement ? -A Prospective Randomized Study in Head and Neck Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

5. Study Description

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.
Detailed Description
Otolaryngologists often use drainage tube after head and neck surgery to reduce hematoma or seroma formation. In addition, the duration of drainage tube placement is closely related to the length of hospital stay. So early removal of drainage tube could eventually shorten the admission period. The factors related to the duration of drainage tube placement include: type of surgery, intra-operative bleeding, underlying disease of coagulation disorders, etc. According to the literatures, the average duration of drainage in head and neck surgery is 4 days. Another study showed that one of the risk factors associated with surgical site infection is the longer drainage duration. Therefore, how to remove drainage tube as soon as possible is crucial to head and neck surgeon.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.This study includes 60 consecutive patients who will undergo head and neck surgery. Those who are allergy to tranexamic acid, history of coagulation disorders, under anti-coagulation therapy will be excluded. Basic data will be recorded along with detail physical examination and operation type. Then they will be divided randomly into study group and control group. Study group will receive tranexamic acid before and after operation while control group not. PT, APTT, level of prothrombin fragments 1+2, D-dimers, plasminogen, α2-antiplasmin, tissue plasminogen activator (tPA), and plasminogen activator inhibitor (PAI-1) will be obtained before and after operation. The drainage amount, duration of drainage tube placement will also be recorded. Relevant variables will be collected and analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Tranexamic acid, head neck surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Transamin
Primary Outcome Measure Information:
Title
Drainage amount
Title
Drainage stay duration
Title
Laboratoy data

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: head and neck neoplasm scheduled for operation Exclusion Criteria: allergy to tranexamic acid history of coagulation disorders under anti-coagulation therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Cheng Chen, MD
Phone
+886-968-950005
First Name & Middle Initial & Last Name or Official Title & Degree
Shih-An Liu, MD, MHA
Phone
+886-936-294749
Email
saliu@vghtc.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-An Liu, MD, MHA
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Tranexamic Acid and Head and Neck Surgery Patients

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