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If Tranexamic Acid Could Reduce the Duration of Drainage Tube Placement ? —A Prospective Randomized Study in Head and Neck Surgery Patients

Phase 3
20 Years
80 Years
Open (Enrolling)
Head and Neck Neoplasms

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Trial Information

If Tranexamic Acid Could Reduce the Duration of Drainage Tube Placement ? —A Prospective Randomized Study in Head and Neck Surgery Patients

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

Inclusion Criteria:

- head and neck neoplasm scheduled for operation

Exclusion Criteria:

- allergy to tranexamic acid

- history of coagulation disorders

- under anti-coagulation therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Drainage amount

Principal Investigator

Shih-An Liu, MD, MHA

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taichung Veterans General Hospital


Taiwan: Department of Health

Study ID:




Start Date:

March 2006

Completion Date:

March 2007

Related Keywords:

  • Head and Neck Neoplasms
  • Tranexamic acid
  • head neck surgery
  • Neoplasms
  • Head and Neck Neoplasms