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Tranexamic Acid and Head and Neck Surgery Patients

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00308880
Enrollment
80
Registered
2006-03-30
Start date
2006-03-31
Completion date
2007-03-31
Last updated
2006-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Keywords

Tranexamic acid, head neck surgery

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.

Interventions

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* head and neck neoplasm scheduled for operation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Drainage amount
Drainage stay duration
Laboratoy data

Countries

Taiwan

Contacts

Primary ContactChih-Cheng Chen, MD
+886-968-950005
Backup ContactShih-An Liu, MD, MHA
saliu@vghtc.gov.tw+886-936-294749

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026