Recruiting PHASE3 Brain Tumor

New treatment option for Brain Tumor

Official title The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

ClinicalTrials.gov ID: NCT06229483

What this study is testing

What is TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION?

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain tumor.

Also referred to as TXA.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The goal of this clinical trial is to test the effect of a drug called tranexamic acid (TXA) on reducing blood loss in participants undergoing surgery to remove brain tumors. The main questions it aims to answer are: 1.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • are the following:
  • Adult male or female, between 18-80 years of age.
  • Patients are scheduled to undergo a craniotomy for tumor resection.
  • Patients/ Substitute Decision Maker have given written consent to participate.

You likely can't join if

  • are the following: Patients who meet any of the following exclusion criteria will not be eligible.
  • Patients with known active or previous history of thromboembolic disease or deep venous thrombosis.
  • Patients with known pre-existing coagulopathy such as hemophilia, Von Willebrand disease, and clotting factor deficiencies.
  • Patients with renal impairment and eGFR \<60 ml/min/1.73 m2 as determined by the lab or calculated by using the Cockcroft Gault formula or end stage...
  • Female people who are pregnant or currently breastfeeding.
  • Patients with Class 3 (high-risk) obesity BMI ≥ to 40.
See the full eligibility criteria
Who can join
  • are the following:
  • Adult male or female, between 18-80 years of age.
  • Patients are scheduled to undergo a craniotomy for tumor resection.
  • Patients/ Substitute Decision Maker have given written consent to participate.
What rules you out
  • are the following: Patients who meet any of the following exclusion criteria will not be eligible.
  • Patients with known active or previous history of thromboembolic disease or deep venous thrombosis.
  • Patients with known pre-existing coagulopathy such as hemophilia, Von Willebrand disease, and clotting factor deficiencies.
  • Patients with renal impairment and eGFR \<60 ml/min/1.73 m2 as determined by the lab or calculated by using the Cockcroft Gault formula or end stage renal disease currently on dialysis.
  • Female people who are pregnant or currently breastfeeding.
  • Patients with Class 3 (high-risk) obesity BMI ≥ to 40.
  • Patients undergoing emergency craniotomy or mini craniotomy or craniectomies.
  • Patients who received embolization prior to surgery.

The study team makes the final eligibility decision.

Where it's taking place

  • Halifax, Nova Scotia, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.