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Tranexamic Acid Reduce Blood Loss in Meningioma Resection

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ClinicalTrials.gov Identifier: NCT04386642
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Pathomporn Pin on, M.D., Chiang Mai University

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.


Condition or disease Intervention/treatment Phase
Meningioma Drug: Tranexamic acid Drug: Placebo Phase 4

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized into two parallel groups by block of four randomization.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patients and outcome assessors are blinded to the drug that will be prepared by a pharmacist in the similar unlabelled 50-ml syringe.
Primary Purpose: Treatment
Official Title: Effect of Tranexamic Acid Infusion to Reduce Intraoperative Blood Loss in Large Meningioma: A Prospective Randomized Double-blind Control Study
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Experiment group
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
Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.
Other Name: group T

Placebo Comparator: Control group
Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.
Drug: Placebo
normal saline solution in a clear 50-ml syringe
Other Name: group N




Primary Outcome Measures :
  1. volume of intraoperative blood loss [ Time Frame: in operating room during surgery ]
    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


Secondary Outcome Measures :
  1. volume of blood being transfused [ Time Frame: during surgery and 24 hour after surgery ]
    volume of pack red cell and other blood component (FFP, platelet)

  2. surgeon rated for the satisfaction on hemostatic scale [ Time Frame: in 2 hours after finish the operation ]
    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.

  3. the extent of tumor removal according to the surgeon decision [ Time Frame: in 2 hours after finish the operation ]
    completely or partially resection is rated by the surgeons

  4. postoperative complications [ Time Frame: in ICU neuro in 24 hours ]
    bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures

  5. the duration of postoperative ventilator use [ Time Frame: number of day remained intubation within 1 week after surgery ]
    remain intubation

  6. the length of neuro-ICU stays [ Time Frame: number of day remained intubation within 1 week after surgery ]
    how long the patient stay in ICU



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386642


Contacts
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Contact: Pathomporn Pin-on, MD 01166868970009 pinon.pathomporn@gmail.com
Contact: Prangmalee Leurcharusmee, MD 01166868970009 prangmalee.l@cmu.ac.th

Locations
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Thailand
Chiang Mai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Pathomporn Pin-on, MD Chiang Mai University
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.

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Responsible Party: Pathomporn Pin on, M.D., Assistant Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT04386642    
Other Study ID Numbers: ANE_07052020
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pathomporn Pin on, M.D., Chiang Mai University:
Tranexamic acid
Meningioma
Blood loss
Additional relevant MeSH terms:
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Meningioma
Hemorrhage
Pathologic Processes
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
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants