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Tranexamic Acid and Head and Neck Surgery Patients

NCT ID: NCT00308880

Last Updated: 2006-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Neoplasms

Keywords

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Tranexamic acid head neck surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Transamin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* head and neck neoplasm scheduled for operation

Exclusion Criteria

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

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Shih-An Liu, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chih-Cheng Chen, MD

Role: CONTACT

Phone: +886-968-950005

Shih-An Liu, MD, MHA

Role: CONTACT

Phone: +886-936-294749

Email: [email protected]

Other Identifiers

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941117/C05186

Identifier Type: -

Identifier Source: secondary_id

TCVGH-957001A

Identifier Type: -

Identifier Source: org_study_id