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Tranexamic Acid and Head and Neck Surgery Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308880
First Posted: March 30, 2006
Last Update Posted: March 30, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taichung Veterans General Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00308880     History of Changes
Other Study ID Numbers: TCVGH-957001A
941117/C05186
First Submitted: March 29, 2006
First Posted: March 30, 2006
Last Update Posted: March 30, 2006
Last Verified: March 2006

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

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