Tranexamic Acid and Head and Neck Surgery Patients

Phase 3

• Conditions: Head and Neck Neoplasms

• Registration Number: NCT00308880
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Status Verified: 2006-03
• Study Start: 2006-03
• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Last Update Submitted: 2006-03-29
• Study First Posted: 2006-03-30
• Last Update Posted: 2006-03-30
• Study Completion: 2007-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• head and neck neoplasm scheduled for operation

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Drainage amount
Drainage stay duration
Laboratoy data

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan