SeizuresSTAMPNCT04595786
The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
A study testing Tranexamic acid and 0.9% saline in people with Seizures and Meningioma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Seizures, Meningioma
- What is being tested?
- Tranexamic acid and 0.9% saline
- 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
- 30 Oct 2020to 11 Jul 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) age 18-80 years
- 2) American Society of Anesthesiologist (ASA) classification score I~III
Who cannot join
- 1) allergic to tranexamic acid
- 2) preoperative seizures
- 3) history of thrombotic disease
- 4) chronic kidney disease
- 5) breastfeeding or pregnancy
- 6) refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.
- Conditions
- Seizures, Meningioma
- Being tested
- Tranexamic acid, 0.9% saline
- Keywords
- meningioma, blood management
- Medical subject headings
- Seizures, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
20mg/kg TXA was prepared in a 50ml syringe for intravenous pump
0.9% salineDrug
0.9% saline was prepared in a 50ml syringe for intravenous pump
| Study group | Role | What they receive |
|---|---|---|
| TXA group | Active comparator | The TXA group will receives Tranexamic acid intraoperative. Receives: Drug: Tranexamic acid |
| Placebo group | Placebo comparator | The TXA group will receives 0.9% saline intraoperative. Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative seizures within 7 days
Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.
Measured: Within 7 days after surgery
Secondary outcomes (5)
The incidence of non-epileptic complications
Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection.
Measured: Within 7 days after the intervention
Estimated intraoperative blood loss
Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml).
Measured: During surgery
The changes in haemoglobin concentrations
The changes in haemoglobin concentrations between baseline and end of surgery.
Measured: During surgery
The intraoperative blood transfusion volume and rate
The intraoperative blood transfusion volume and rate.
Measured: During surgery
The intraoperative cell saver volume and rate
The intraoperative cell saver volume and rate.
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 posted22 Oct 2020
- Study start30 Oct 2020
- Primary completion11 Jan 2024
- Study completion11 Jul 2024
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 SeizuresStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming Peng, M.D., Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595786
- Sponsor's protocol ID
- ChiECRCT20200224
- Acronym
- STAMP
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2020
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual, de-identified participant data will be shared two years after the publication of primary outcome data, by request from any qualified investigator following approval of a protocol, statistical analysis plan, and receipt of a signed data access agreement via the research office and the Beijing Tiantan Hospital Ethics Committees for the project and data release.
Publications
Li S, Liu M, Yang J, Yan X, Wu Y, Zhang L, Zeng M, Zhou D, Peng Y, Sessler DI. Intravenous tranexamic acid for intracerebral meningioma resections: A randomized, parallel-group, non-inferiority trial. J Clin Anesth. 2024 Feb;92:111285. doi: 10.1016/j.jclinane.2023.111285. Epub 2023 Oct 17.
PubMed 37857168Li S, Yan X, Li R, Zhang X, Ma T, Zeng M, Dong J, Wang J, Liu X, Peng Y. Safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection: protocol for a randomised, parallel-group, placebo control, non-inferiority trial. BMJ Open. 2022 Feb 2;12(2):e052095. doi: 10.1136/bmjopen-2021-052095.
PubMed 35110315
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
- ClinicalTrials.gov ID
- NCT04595786
- Acronym / sponsor ID
- STAMP / ChiECRCT20200224
- Conditions
- Seizures, Meningioma
- Keywords
- meningioma, blood management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 22 Oct 2020 (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.
Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.
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 |
|---|---|---|
| TXA group | Active comparator | Drug: Tranexamic acidThe TXA group will receives Tranexamic acid intraoperative. |
| Placebo group | Placebo comparator | Drug: 0.9% salineThe TXA group will receives 0.9% saline intraoperative. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) age 18-80 years
- 2) American Society of Anesthesiologist (ASA) classification score I~III
Key exclusion criteria (6 listed)
- 1) allergic to tranexamic acid
- 2) preoperative seizures
- 3) history of thrombotic disease
- 4) chronic kidney disease
- 5) breastfeeding or pregnancy
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 acid20mg/kg TXA was prepared in a 50ml syringe for intravenous pump | Drug | TXA group |
| 0.9% saline0.9% saline was prepared in a 50ml syringe for intravenous pump | Drug | Placebo group |
Primary outcome
Early postoperative seizures within 7 days
Time frame: Within 7 days after surgery
Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.
5 secondary outcomes
The incidence of non-epileptic complications
Time frame: Within 7 days after the intervention
Estimated intraoperative blood loss
Time frame: During surgery
The changes in haemoglobin concentrations
Time frame: During surgery
The intraoperative blood transfusion volume and rate
Time frame: During surgery
The intraoperative cell saver volume and rate
Time frame: During 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 4 Mar 2025.
- Derived from this study: PubMed 37857168Li S, Liu M, Yang J, Yan X, Wu Y, Zhang L, Zeng M, Zhou D, Peng Y, Sessler DI. Intravenous tranexamic acid for intracerebral meningioma resections: A randomized, parallel-group, non-inferiority trial. J Clin Anesth. 2024 Feb;92:111285. doi: 10.1016/j.jclinane.2023.111285. Epub 2023 Oct 17.
- Derived from this study: PubMed 35110315Li S, Yan X, Li R, Zhang X, Ma T, Zeng M, Dong J, Wang J, Liu X, Peng Y. Safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection: protocol for a randomised, parallel-group, placebo control, non-inferiority trial. BMJ Open. 2022 Feb 2;12(2):e052095. doi: 10.1136/bmjopen-2021-052095.
- Individual participant dataSharing planned: Yes. Individual, de-identified participant data will be shared two years after the publication of primary outcome data, by request from any qualified investigator following approval of a protocol, statistical analysis plan, and receipt of a signed data access agreement via the research office and the Beijing Tiantan Hospital Ethics Committees for the project and data release.
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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.
Yuming Peng, M.D., Ph.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 Tranexamic acid and 0.9% saline in people with Seizures and Meningioma, 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 2 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 4 Mar 2025. 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?
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?
Early postoperative seizures within 7 days (time frame: Within 7 days after 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 NCT04595786, 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 4 Mar 2025.