Tranexamic Acid Reduce Blood Loss in Meningioma Resection

NCT04386642 | Unknown Phase 4 DMC

• 1 other identifier: ANE_07052020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Meningioma

Keywords

Tranexamic acid; Meningioma; Blood loss

Outcome Measures

Primary Outcomes (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

  in operating room during surgery

Secondary Outcomes (6)

• volume of blood being transfused

  during surgery and 24 hour after surgery

• surgeon rated for the satisfaction on hemostatic scale

  in 2 hours after finish the operation

• the extent of tumor removal according to the surgeon decision

  in 2 hours after finish the operation

• postoperative complications

  in ICU neuro in 24 hours

• the duration of postoperative ventilator use

  number of day remained intubation within 1 week after surgery

Study Arms (2)

Experiment group

EXPERIMENTAL

Each 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.

Drug: Tranexamic acid

Control group

PLACEBO COMPARATOR

Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.

Drug: Placebo

Interventions

Tranexamic acid DRUG

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

Also known as: group T

Experiment group

Placebo DRUG

normal saline solution in a clear 50-ml syringe

Also known as: group N

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Meningioma; Hemorrhage

Interventions

Tranexamic Acid; Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pathomporn Pin-on, MD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pathomporn Pin-on, MD

CONTACT

01166868970009; pinon.pathomporn@gmail.com

Prangmalee Leurcharusmee, MD

CONTACT

01166868970009; prangmalee.l@cmu.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients and outcome assessors are blinded to the drug that will be prepared by a pharmacist in the similar unlabelled 50-ml syringe.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The patients will be randomized into two parallel groups by block of four randomization.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 13, 2020
• Study Start: September 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)