Cervical MyelopathyNCT01027546
Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty
A study testing Tranexamic Acid in people with Cervical Myelopathy, run by Yodakubo Hospital.
Trial summary
The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to May 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed.
Who cannot join
- Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.
About this study
The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.
Read the detailed description
Tranexamic acid, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, limited numbers of well-controlled trials in spinal surgery have been conducted due to heterogeneity in the performed surgical procedures.
- Conditions
- Cervical Myelopathy
- Being tested
- Tranexamic Acid
- Keywords
- perioperative blood loss, spinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision
| Study group | Role | What they receive |
|---|---|---|
| placebo, tranexamic acid | Placebo comparator | Not described Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative blood loss
Measured: during and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yodakubo Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027546
- Sponsor's protocol ID
- YODA-0001
- Status last verified
- May 2008
- First submitted
- 7 Dec 2009
- Last updated
- 8 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty
- ClinicalTrials.gov ID
- NCT01027546
- Acronym / sponsor ID
- YODA-0001
- Conditions
- Cervical Myelopathy
- Keywords
- perioperative blood loss, spinal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yodakubo HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 8 Dec 2009 (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.
The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.
Detailed description
Tranexamic acid, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, limited numbers of well-controlled trials in spinal surgery have been conducted due to heterogeneity in the performed surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placebo, tranexamic acid | Placebo comparator | Drug: Tranexamic Acid |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed.
Key exclusion criteria (1 listed)
- Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.
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 |
|---|---|---|
| Tranexamic AcidAdminister 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision | Drug | placebo, tranexamic acid |
Primary outcome
perioperative blood loss
Time frame: during and after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2009.
Related trials for Cervical Myelopathy
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Stimulation-based Therapy to Improve Balance in DCM
Degenerative Cervical Myelopathy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Cervical Myelopathy, run by Yodakubo Hospital.
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 1 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: finished, as of the sponsor's last update on 8 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative blood loss (time frame: during and after surgery). 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 8 Dec 2009.