Head and Neck NeoplasmsPhase 3NCT00308880
Tranexamic Acid and Head and Neck Surgery Patients
A Phase 3 study testing Transamin in people with Head and Neck Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Transamin
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- head and neck neoplasm scheduled for operation
Who cannot join
- allergy to tranexamic acid
- history of coagulation disorders
- under anti-coagulation therapy
Trial locations and contacts
1 site in 1 country.
Chih-Cheng Chen, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
About this study
Official title: If Tranexamic Acid Could Reduce the Duration of Drainage Tube Placement ? -A Prospective Randomized Study in Head and Neck Surgery Patients
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.
Read the 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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Transamin
- Keywords
- Tranexamic acid, head neck surgery
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransaminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainage amount
Drainage stay duration
Laboratoy data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startMar 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shih-An Liu, MD, MHA, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308880
- Sponsor's protocol ID
- TCVGH-957001A
- Other IDs
- 941117/C05186
- Status last verified
- Mar 2006
- First submitted
- 29 Mar 2006
- Last updated
- 30 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- If Tranexamic Acid Could Reduce the Duration of Drainage Tube Placement ? -A Prospective Randomized Study in Head and Neck Surgery Patients
- ClinicalTrials.gov ID
- NCT00308880
- Acronym / sponsor ID
- TCVGH-957001A
- Conditions
- Head and Neck Neoplasms
- Keywords
- Tranexamic acid, head neck surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Mar 2007
- First posted
- 30 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- head and neck neoplasm scheduled for operation
Key exclusion criteria (3 listed)
- allergy to tranexamic acid
- history of coagulation disorders
- under anti-coagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transamin | Drug | – |
Primary outcome
Drainage amount
Drainage stay duration
Laboratoy data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Cheng Chen, MD contact
Shih-An Liu, MD, MHA principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transamin in people with Head and Neck Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Cheng Chen, MD (+886-968-950005), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drainage amount. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2006.