Tranexamic Acid Reduce Blood Loss in Meningioma Resection
Primary Purpose
Meningioma
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Meningioma focused on measuring Tranexamic acid, Meningioma, Blood loss
Eligibility 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)
Sites / Locations
- Chiang Mai University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experiment group
Control group
Arm Description
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.
Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.
Outcomes
Primary Outcome Measures
volume of intraoperative blood loss
volume of blood presented in the suction bottle subtracted by the amount of water that the surgeon used in the surgical field
the blood from the dry (30 ml) and wet swab (50 ml)
serial Hgb / Hct periodically during surgery and compare to those obtain before surgery
Secondary Outcome Measures
volume of blood being transfused
volume of pack red cell and other blood component (FFP, platelet)
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.
the extent of tumor removal according to the surgeon decision
completely or partially resection is rated by the surgeons
postoperative complications
bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures
the duration of postoperative ventilator use
remain intubation
the length of neuro-ICU stays
how long the patient stay in ICU
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04386642
Brief Title
Tranexamic Acid Reduce Blood Loss in Meningioma Resection
Official Title
Effect of Tranexamic Acid Infusion to Reduce Intraoperative Blood Loss in Large Meningioma: A Prospective Randomized Double-blind Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Background and Literature review:
Meningioma
Coagulation in craniotomy to remove meningioma
Bleeding in craniotomy to remove meningioma
Tranexamic acid (TXA)
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma
Keywords
Tranexamic acid, Meningioma, Blood loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomized into two parallel groups by block of four randomization.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
group T
Intervention Description
Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
group N
Intervention Description
normal saline solution in a clear 50-ml syringe
Primary Outcome Measure Information:
Title
volume of intraoperative blood loss
Description
volume of blood presented in the suction bottle subtracted by the amount of water that the surgeon used in the surgical field
the blood from the dry (30 ml) and wet swab (50 ml)
serial Hgb / Hct periodically during surgery and compare to those obtain before surgery
Time Frame
in operating room during surgery
Secondary Outcome Measure Information:
Title
volume of blood being transfused
Description
volume of pack red cell and other blood component (FFP, platelet)
Time Frame
during surgery and 24 hour after surgery
Title
surgeon rated for the satisfaction on hemostatic scale
Description
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.
Time Frame
in 2 hours after finish the operation
Title
the extent of tumor removal according to the surgeon decision
Description
completely or partially resection is rated by the surgeons
Time Frame
in 2 hours after finish the operation
Title
postoperative complications
Description
bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures
Time Frame
in ICU neuro in 24 hours
Title
the duration of postoperative ventilator use
Description
remain intubation
Time Frame
number of day remained intubation within 1 week after surgery
Title
the length of neuro-ICU stays
Description
how long the patient stay in ICU
Time Frame
number of day remained intubation within 1 week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pathomporn Pin-on, MD
Phone
01166868970009
Email
pinon.pathomporn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prangmalee Leurcharusmee, MD
Phone
01166868970009
Email
prangmalee.l@cmu.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pathomporn Pin-on, MD
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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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Tranexamic Acid Reduce Blood Loss in Meningioma Resection
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