Tranexamic AcidNCT05230381
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection
A study testing Continous infusion and Single infusion in people with Tranexamic Acid and Intraoperative Blood Loss, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tranexamic Acid, Intraoperative Blood Loss, Meningioma
- What is being tested?
- Continous infusion and Single infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 30 Jun 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter >5cm on brain image.
- Age between 18-65 years.
- American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
- Obtain written informed consent.
Who cannot join
- Allergic to tranexamic acid.
- History of thrombotic disease.
- History of chronic kidney disease
- Receiving other anticoagulation or antiplatelet treatment.
- Refuse to provide written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Shu Li, M.D., 13699223065, lishu@bjtth.org
About this study
Official title: Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial
Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.
- Conditions
- Tranexamic Acid, Intraoperative Blood Loss, Meningioma
- Being tested
- Continous infusion, Single infusion, Placebo
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous infusionDrug
The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.
Single infusionDrug
The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.
PlaceboDrug
The 0.9% saline is administered with the same volume at the same speed as the other group.
| Study group | Role | What they receive |
|---|---|---|
| Continous infusion group | Active comparator | Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid. Receives: Drug: Continous infusion |
| Single infusion group | Active comparator | Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline. Receives: Drug: Single infusion |
| Placebo group | Placebo comparator | Infusion with same volume of 0.9% saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated intra-operative blood loss
Estimated intra-operative blood loss is assessed as following formula:collected blood volume in the suction canister (mL) - the volume of flushing (mL) + the volume from gauze tampon (mL).
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start15 Jun 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tranexamic AcidStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Li, Beijing Tiantan Hospital
- Investigators
- Shu Li, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230381
- Sponsor's protocol ID
- 2022018
- Status last verified
- Aug 2022
- First submitted
- 5 Jan 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li S, Liu M, Zhang L, Ren Y, Wu Y, Yin X, Zeng M, Zhou D, Sessler DI, Peng Y. Effect of tranexamic acid on blood loss in patients undergoing resection of large meningioma: a randomized clinical trial. Sci Rep. 2026 May 11;16(1):21458. doi: 10.1038/s41598-026-52276-2.
PubMed 42115323Yu H, Liu M, Zhang X, Ma T, Yang J, Wu Y, Wang J, Li M, Wang J, Zeng M, Zhang L, Jin H, Liu X, Li S, Peng Y. The effect of tranexamic acid on intraoperative blood loss in patients undergoing brain meningioma resections: Study protocol for a randomized controlled trial. PLoS One. 2023 Aug 31;18(8):e0290725. doi: 10.1371/journal.pone.0290725. eCollection 2023.
PubMed 37651373
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05230381
- Acronym / sponsor ID
- 2022018
- Conditions
- Tranexamic Acid, Intraoperative Blood Loss, Meningioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Feb 2022 (actual)
- 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.
Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continous infusion group | Active comparator | Drug: Continous infusionInfusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid. |
| Single infusion group | Active comparator | Drug: Single infusionInfusion with 20mg/kg tranexamic acid and same volume 0.9% saline. |
| Placebo group | Placebo comparator | Drug: PlaceboInfusion with same volume of 0.9% saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter >5cm on brain image.
- Age between 18-65 years.
- American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
- Obtain written informed consent.
Key exclusion criteria (5 listed)
- Allergic to tranexamic acid.
- History of thrombotic disease.
- History of chronic kidney disease
- Receiving other anticoagulation or antiplatelet treatment.
- Refuse to provide written informed consent
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 |
|---|---|---|
| Continous infusionThe 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion. | Drug | Continous infusion group |
| Single infusionThe 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline. | Drug | Single infusion group |
| PlaceboThe 0.9% saline is administered with the same volume at the same speed as the other group. | Drug | Placebo group |
Primary outcome
Estimated intra-operative blood loss
Time frame: During surgery
Estimated intra-operative blood loss is assessed as following formula:collected blood volume in the suction canister (mL) - the volume of flushing (mL) + the volume from gauze tampon (mL).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 42115323Li S, Liu M, Zhang L, Ren Y, Wu Y, Yin X, Zeng M, Zhou D, Sessler DI, Peng Y. Effect of tranexamic acid on blood loss in patients undergoing resection of large meningioma: a randomized clinical trial. Sci Rep. 2026 May 11;16(1):21458. doi: 10.1038/s41598-026-52276-2.
- Derived from this study: PubMed 37651373Yu H, Liu M, Zhang X, Ma T, Yang J, Wu Y, Wang J, Li M, Wang J, Zeng M, Zhang L, Jin H, Liu X, Li S, Peng Y. The effect of tranexamic acid on intraoperative blood loss in patients undergoing brain meningioma resections: Study protocol for a randomized controlled trial. PLoS One. 2023 Aug 31;18(8):e0290725. doi: 10.1371/journal.pone.0290725. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Shu Li, M.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous infusion and Single infusion in people with Tranexamic Acid and Intraoperative Blood Loss, run by Beijing Tiantan Hospital at 1 site in China.
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 5 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 29 Aug 2022. 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 China. 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.
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 Shu Li, M.D. (8613699223065, lishu@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated intra-operative blood loss (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230381, which also lists 2 linked publications.
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 29 Aug 2022.