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MeningiomaPhase 4NCT04386642

Tranexamic Acid Reduce Blood Loss in Meningioma Resection

A Phase 4 study testing Tranexamic acid in people with Meningioma, run by Chiang Mai University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In neurosurgical setting, a large sample size trials of tranexamic acid (TXA) has been limited to TBI and SAH. The evidence of TXA in brain tumor was scarce. A few case reports support the role of TXA in brain tumor patients with significant intraoperative bleeding and difficult achieving hemostasis. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Meningioma
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
44 participants
Where
1 siteThailand
Study dates
1 Sep 2021to 30 Sep 2022
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The patients whose aged 18 to 60 years
  • The patients who was diagnosed intracranial meningioma
  • The radio-graphic finding of tumor diameter > 5 cm in at least 2 dimensions
  • The patients have written informed consent
  • The patients is scheduled for elective craniotomy to remove tumor

Who cannot join

  • Patients who refuse to participate in this study
  • Patients with recurrent tumor
  • The patient is set operation for intracranial tissue biopsy
  • The patients with history of TXA allergy
  • The pregnant patients
  • The patients with history of significant thromboembolic episode
  • The patients with significant renal dysfunction (GFR ≤ 50 ml/min)

Trial locations and contacts

1 site in 1 country.

Pathomporn Pin-on, MD contact

01166868970009

pinon.pathomporn@gmail.com

Prangmalee Leurcharusmee, MD contact

01166868970009

prangmalee.l@cmu.ac.th

Thailand1 site

  • Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: Effect of Tranexamic Acid Infusion to Reduce Intraoperative Blood Loss in Large Meningioma: A Prospective Randomized Double-blind Control Study

In neurosurgical setting, a large sample size trials of tranexamic acid (TXA) has been limited to TBI and SAH.

The evidence of TXA in brain tumor was scarce. A few case reports support the role of TXA in brain tumor patients with significant intraoperative bleeding and difficult achieving hemostasis. To prove the benefit of TXA for an attenuation of blood loss in brain tumor patients, research with a larger sample size is required. This prospective, randomized double-blind controlled study will be conducted to evaluate the effect of TXA in reducing blood loss and blood transfusion in patients with intracranial meningiomas, diameter > 5 cm in at least 2 dimensions from the latest radiographic findings.

Read the detailed description

Background and Literature review:

  1. Meningioma
  2. Coagulation in craniotomy to remove meningioma
  3. Bleeding in craniotomy to remove meningioma
  4. Tranexamic acid (TXA)
  5. Knowledge gap The topics shown above has been reviewed to conduct a prospective randomized double-blind, placebo controlled study.

To prove the study hypothesis: Will intraoperative TXA administration in adult patients scheduled for craniotomy to remove large meningioma decrease blood loss?

Conditions
Meningioma
Being tested
Tranexamic acid, Placebo
Keywords
Tranexamic acid, Meningioma, Blood loss
Medical subject headings
Meningioma, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Also called group T

    Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.

  • PlaceboDrug

    Also called group N

    normal saline solution in a clear 50-ml syringe

Study groups in NCT04386642
Study groupRoleWhat they receive
Experiment groupExperimentalEach ampule contains TXA 250 mg. TXA preparation is 2000 mg dilute in normal saline 50 ml to get the concentration of 40 mg/ml. TXA will be administered 20 mg/kg loading over 20 min before skin incision followed by a maintenance infusion of 0.025 ml/kg/h (1 mg/kg/h) until the end of operation.
Receives: Drug: Tranexamic acid
Control groupPlacebo comparatorNormal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. volume of intraoperative blood loss

    1. volume of blood presented in the suction bottle subtracted by the amount of water that the surgeon used in the surgical field
    2. the blood from the dry (30 ml) and wet swab (50 ml)
    3. serial Hgb / Hct periodically during surgery and compare to those obtain before surgery

    Measured: in operating room during surgery

Secondary outcomes (6)

  1. volume of blood being transfused

    volume of pack red cell and other blood component (FFP, platelet)

    Measured: during surgery and 24 hour after surgery

  2. surgeon rated for the satisfaction on hemostatic scale

    The surgeon will be informed about a Likert-type scale which is designed for clinical studies. The surgeon's satisfaction on hemostatic scale is a 3-graded scale modified from 5-graded validated bleeding severity scale. The original version is shown in the table 1. The surgeon will judge his satisfaction on hemostatic quality based on the most critical period or the overview of the surgical procedure. Even the long operative time, there will be one rate represent surgeon's opinion on hemostatic quality.

    Measured: in 2 hours after finish the operation

  3. the extent of tumor removal according to the surgeon decision

    completely or partially resection is rated by the surgeons

    Measured: in 2 hours after finish the operation

  4. postoperative complications

    bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures

    Measured: in ICU neuro in 24 hours

  5. the duration of postoperative ventilator use

    remain intubation

    Measured: number of day remained intubation within 1 week after surgery

  6. the length of neuro-ICU stays

    how long the patient stay in ICU

    Measured: number of day remained intubation within 1 week after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

Resources

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
Model description
The patients will be randomized into two parallel groups by block of four randomization.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386642
Sponsor's protocol ID
ANE_07052020
Status last verified
Jan 2021
First submitted
7 May 2020
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 1. Ostrom QT, Cioffi G, Gittleman H, Patil N, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2012-2016. Neuro Oncol. 2019 Nov 1;21(Supplement_5): v1-v100. doi: 10.1093/neuonc/noz150. 2. Islim, A.I., Mohan, M., Moon, R.D.C. et al. Incidental intracranial meningiomas: a systematic review and meta-analysis of prognostic factors and outcomes. J Neurooncol 142, 211-221 (2019). https://doi.org/10.1007/s11060-019-03104-3 3. Lemée, J., Corniola, M.V., Da Broi, M. et al. Extent of Resection in Meningioma: Predictive Factors and Clinical Implications. Sci Rep 9, 5944 (2019). https://doi.org/10.1038/s41598-019-42451-z 4. Choy W, Kim W, Nagasawa D, Stramotas S, Yew A, Gopen Q, Parsa AT, Yang I. The molecular genetics and tumor pathogenesis of meningiomas and the future directions of meningioma treatments. Neurosurg Focus. 2011 May;30(5): E6. doi: 10.3171/2011.2. FOCUS1116. 5. Sawaya R, Rämö OJ, Shi ML, Mandybur G. Biological significance of tissue plasminogen activator content in brain tumors. J Neurosurg. 1991 Mar;74(3):480-6. 6. Goh KY, Poon WS, Chan DT, Ip CP. Tissue plasminogen activator expression in meningiomas and glioblastomas. Clin Neurol Neurosurg. 2005 Jun;107(4):296-300. 7. Goh KY, Tsoi WC, Feng CS, Wickham N, Poon WS. Haemostatic changes during surgery for primary brain tumours. J Neurol Neurosurg Psychiatry. 1997 Sep;63(3):334-8. 8. J. E. Brecknell, C. A. Mclean, H. Hirano & G. M. Malham. Disseminated intravascular coagulation complicating resection of a malignant meningioma, British Journal of Neurosurgery. 2006, 20:4, 239-241, DOI: 10.1080/02688690600852647 9. Velez AM, Friedman WA. Disseminated intravascular coagulation during resection of a meningioma: case report. Neurosurgery.2011Apr;68(4): E1165-9; discussion E1169.doi: 10.1227/ NEU. 0b013 e31820a18 1a 10. Hsu SY, Huang YH. Characterization and prognostic implications of significant blood loss during intracranial meningioma surgery. Transl Cancer Res 2016;5(6):797-804. doi: 10.21037/tcr.2016.11.72. 11. Wu WC, Trivedi A, Friedmann PD, et al. Association between hospital intraoperative blood transfusion practices for surgical blood loss and hospital surgical mortality rates. Ann Surg 2012; 255:708-14. 12. Tsyben A, Surour M, Budohoski K, et alP42 Predicting bleeding risk during meningioma surgery. Journal of Neurology, Neurosurgery & Psychiatry 2019;90: e35. 13. Yates, J., Perelman, I., Khair, S., Taylor, J., Lampron, J., Tinmouth, A. and Saidenberg, E. (2019), Exclusion criteria and adverse events in perioperative trials of tranexamic acid: a systematic review and meta-analysis. Transfusion, 59: 806-824. doi:10.1111/trf.15030 14. Chauncey JM, Wieters JS. Tranexamic Acid. [Updated 2019 Dec 16]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532909/ 15. Shakur H, Roberts I, Bautista R, et al; CRASH-2 trial collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomized, placebo-controlled trial. Lancet. 2010; 376:23-32. 16. Roberts I, Shakur H, Afolabi A, et al; CRASH-2 collaborators. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomized controlled trial. Lancet. 2011; 377:1096- 1101, 1101 e1091-1092. 17. WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomized, double-blind, placebo-controlled trial. Lancet. 2017; 389:2105-2116. 18. Gayet-Ageron A, Prieto-Merino D, Ker K, Shakur H, Ageron FX, Roberts I; Antifibrinolytic Trials Collaboration. Effect of treatment delay on the effectiveness and safety of antifibrinolytics in acute severe haemorrhage: a meta-analysis of individual patient-level data from 40 138 bleeding patients. Lancet. 2018; 391:125-132. 19. Hooda B, Muthuchellappan R. Tranexamic Acid in Neuroanesthesia and Neurocritical Care: Time for Its Critical Appraisal. J Neuroanaesthesiol Crit Care 2019; 6:257-266. 20. Ker K, Prieto-Merino D, Roberts I. Systematic review, meta-analysis and meta-regression of the effect of tranexamic acid on surgical blood loss. Br J Surg 2013;100(10):1271-1279.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic acid in people with Meningioma, run by Chiang Mai 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 5 inclusion and 7 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 27 Jan 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pathomporn Pin-on, MD (01166868970009, pinon.pathomporn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

volume of intraoperative blood loss (time frame: in operating room 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 NCT04386642, which also lists 1 linked publication.

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 27 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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