Tranexamic Acid and Head and Neck Surgery Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT00308880
First received: March 29, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Head and Neck Neoplasms
Drug: Transamin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: If Tranexamic Acid Could Reduce the Duration of Drainage Tube Placement ? —A Prospective Randomized Study in Head and Neck Surgery Patients

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Drainage amount
  • Drainage stay duration
  • Laboratoy data

Estimated Enrollment: 80
Study Start Date: March 2006
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • head and neck neoplasm scheduled for operation

Exclusion Criteria:

  • allergy to tranexamic acid
  • history of coagulation disorders
  • under anti-coagulation therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308880

Contacts
Contact: Chih-Cheng Chen, MD +886-968-950005
Contact: Shih-An Liu, MD, MHA +886-936-294749 saliu@vghtc.gov.tw

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Shih-An Liu, MD, MHA Taichung Veterans General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00308880     History of Changes
Other Study ID Numbers: TCVGH-957001A, 941117/C05186
Study First Received: March 29, 2006
Last Updated: March 29, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by Taichung Veterans General Hospital:
Tranexamic acid
head neck surgery

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014