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
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|
Background and Literature review:
- 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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|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.|
|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|
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.
normal saline solution in a clear 50-ml syringe
Other Name: group N
- volume of intraoperative blood loss [ Time Frame: in operating room during surgery ]
- 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
- 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)
- 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.
- 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
- 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
- the duration of postoperative ventilator use [ Time Frame: number of day remained intubation within 1 week after surgery ]remain intubation
- 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
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
|Contact: Pathomporn Pin-on, MDemail@example.com|
|Contact: Prangmalee Leurcharusmee, MDfirstname.lastname@example.org|
|Chiang Mai University|
|Chiang Mai, Thailand, 50200|
|Principal Investigator:||Pathomporn Pin-on, MD||Chiang Mai University|