BleedingPhase 4NCT01643135
Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid
A Phase 4 study testing tranexamic acid and 0.9% NaCl in people with Bleeding, run by Mahidol University at 1 site in Thailand.
Trial summary
Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bleeding
- What is being tested?
- tranexamic acid and 0.9% NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Dec 2013
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has laminectomy with instrumentation or equal or more than 3 levels laminectomy
- age 18-65 years
- ASA 1-3
- elective operation
Who cannot join
- allergy to tranexamic acid
- anemia (Hb<12 g/dl in female or Hb<13 g/dl in male)
- history of CVT, IHD, PE, strokes
- liver disease
- chronic kidney disease with creatinie>2.0 mg/dl
- receive anticoagulant or coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction Perioperative Bleeding in Laminectomy With Instrumentation or More Than or Equal to 3 Levels Laminectomy: The Comparison Between Placebo, and Double Doses of Tranexamic Acid (15 mg/kg and 15 mg/kg)
Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).
Read the detailed description
78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.
- Conditions
- Bleeding
- Being tested
- tranexamic acid, 0.9% NaCl
- Keywords
- tranexamic acid, bleeding, blood transfusion, spine surgery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
Also called transamine (Daiichi-Sankyo, Japan)
Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)
0.9% NaClDrug
Also called NSS
0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Active comparator | Tranexamic acid (15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will given before induction and the second dose(15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will be given at 3 hours after the first dose. Receives: Drug: tranexamic acid |
| 0.9% NaCl | Placebo comparator | 0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative blood loss
Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage
Measured: 24 hours
Secondary outcomes (1)
perioperative blood transfusion
When the blood loss more than acceptable and the hematocrit below 30%, the packed red cell will be given.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manee Raksakietisak, Mahidol University
- Investigators
- Manee Raksakietisak, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643135
- Sponsor's protocol ID
- si248/2012
- Status last verified
- Dec 2013
- First submitted
- 16 Jul 2012
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction Perioperative Bleeding in Laminectomy With Instrumentation or More Than or Equal to 3 Levels Laminectomy: The Comparison Between Placebo, and Double Doses of Tranexamic Acid (15 mg/kg and 15 mg/kg)
- ClinicalTrials.gov ID
- NCT01643135
- Acronym / sponsor ID
- si248/2012
- Conditions
- Bleeding
- Keywords
- tranexamic acid, bleeding, blood transfusion, spine surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Jul 2012 (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 has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).
Detailed description
78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Active comparator | Drug: tranexamic acidTranexamic acid (15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will given before induction and the second dose(15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will be given at 3 hours after the first dose. |
| 0.9% NaCl | Placebo comparator | Drug: 0.9% NaCl0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- has laminectomy with instrumentation or equal or more than 3 levels laminectomy
- age 18-65 years
- ASA 1-3
- elective operation
Key exclusion criteria (6 listed)
- allergy to tranexamic acid
- anemia (Hb<12 g/dl in female or Hb<13 g/dl in male)
- history of CVT, IHD, PE, strokes
- liver disease
- chronic kidney disease with creatinie>2.0 mg/dl
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 acidAlso: transamine (Daiichi-Sankyo, Japan)Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo) | Drug | tranexamic acid |
| 0.9% NaClAlso: NSS0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid | Drug | 0.9% NaCl |
Primary outcome
perioperative blood loss
Time frame: 24 hours
Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage
1 secondary outcome
perioperative blood transfusion
Time frame: 24 hours
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 18 Dec 2013.
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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.
Manee Raksakietisak, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tranexamic acid and 0.9% NaCl in people with Bleeding, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 6 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 18 Dec 2013. 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 Thailand. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 24 hours). 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 18 Dec 2013.