Meningioma
Conditions
Keywords
Tranexamic acid, Meningioma, Blood loss
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: 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?
Interventions
DRUGTranexamic acid
Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.
DRUGPlacebo
normal saline solution in a clear 50-ml syringe
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
The patients will be randomized into two parallel groups by block of four randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume of intraoperative blood loss | 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
| Measure | Time frame | Description |
|---|---|---|
| surgeon rated for the satisfaction on hemostatic scale | 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 | in 2 hours after finish the operation | completely or partially resection is rated by the surgeons |
| volume of blood being transfused | during surgery and 24 hour after surgery | volume of pack red cell and other blood component (FFP, platelet) |
| the duration of postoperative ventilator use | number of day remained intubation within 1 week after surgery | remain intubation |
| the length of neuro-ICU stays | number of day remained intubation within 1 week after surgery | how long the patient stay in ICU |
| postoperative complications | in ICU neuro in 24 hours | bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures |
Countries
Thailand
Contacts
Primary ContactPathomporn Pin-on, MD
Backup ContactPrangmalee Leurcharusmee, MD
Outcome results
None listed