Tranexamic Acid Reduce Blood Loss in Meningioma Resection

Chiang Mai University44 enrolled

Overview

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.

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Meningioma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: in operating room during surgery

Secondary Outcomes

volume of blood being transfused

volume of pack red cell and other blood component (FFP, platelet)

Time frame: during surgery and 24 hour after surgery

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.

Time frame: in 2 hours after finish the operation

the extent of tumor removal according to the surgeon decision

completely or partially resection is rated by the surgeons

Time frame: in 2 hours after finish the operation

postoperative complications

bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures

Time frame: in ICU neuro in 24 hours

the duration of postoperative ventilator use

remain intubation

Time frame: number of day remained intubation within 1 week after surgery

the length of neuro-ICU stays

how long the patient stay in ICU