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Anti-fibrinolytic agent

Tranexamic Acid for Brain Tumor

Phase 3
Recruiting
Led By Stephen Lownie, MD
Research Sponsored by Stephen Lownie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial is testing a drug called tranexamic acid (TXA) to see if it can reduce blood loss in patients having surgery to remove brain tumors. They want to know if a high dose

Who is the study for?
This trial is for adults aged 18-80 who are scheduled to have brain surgery (craniotomy) to remove a tumor. They must be able to give written consent themselves or through a decision maker.Check my eligibility
What is being tested?
The study tests if tranexamic acid (TXA), given as an initial dose and then as an infusion during surgery, can reduce blood loss in patients having brain tumor removal surgeries compared to a placebo.See study design
What are the potential side effects?
Possible side effects of TXA may include nausea, vomiting, diarrhea, dizziness, orthostatic hypotension (a form of low blood pressure), and risks associated with clotting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimated intraoperative blood loss
Reoperation or disability or death due to intracranial hemorrhage within 30 days
Secondary outcome measures
Length of intensive care unit (ICU)/hospital stay
Length of operation
Medication related risks, including seizure, thromboembolic event
+8 more

Side effects data

From 2017 Phase 4 trial • 246 Patients • NCT02030821
2%
Hematoma/Seroma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty
Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Tranexamic Acid (TXA) - Total Hip Arthroplasty
Tranexamic Acid (TXA) - Total Knee Arthroplasty

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic AcidExperimental Treatment1 Intervention
Participants will be randomized in a 1:1 ratio to receive tranexamic acid 20 mg/kg IV bolus or identical volume of placebo 0.9 % NaCl within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, or identical volume of placebo 0.9 % NaCl, for the duration of surgery. Treatment is blinded.
Group II: Matching PlaceboPlacebo Group1 Intervention
Participants will be randomized in a 1:1 ratio to receive tranexamic acid 20 mg/kg IV bolus or identical volume of placebo 0.9 % NaCl within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, or identical volume of placebo 0.9 % NaCl, for the duration of surgery. Treatment is blinded.

Find a Location

Who is running the clinical trial?

Dalhousie UniversityOTHER
167 Previous Clinical Trials
403,036 Total Patients Enrolled
Stephen LownieLead Sponsor
Stephen Lownie, MDPrincipal InvestigatorNova Scotia Health Authority- Queen Elizabeth II HSC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to participate in this research investigation?

"The research seeks 102 individuals aged 18 to 80 diagnosed with a brain tumor who are scheduled for a craniotomy. Essential requirements include being an adult of either gender within the specified age range and providing written consent, either personally or through a surrogate decision-maker, to join the study."

Answered by AI

Is the trial open to individuals younger than 60 years old?

"Individuals aged 18 to 80 years are eligible for enrollment in this research study."

Answered by AI

What is the safety profile of Tranexamic Acid in individuals?

"According to our assessments at Power, the safety rating for Tranexamic Acid is 3 due to it being a Phase III trial with existing efficacy data and robust safety records."

Answered by AI

What is the number of participants currently involved in this clinical investigation?

"Yes, the details on clinicaltrials.gov indicate that this research is actively seeking participants. The initial posting of the study was on April 3rd, 2024, and it was last revised on the same day. A total of 102 individuals are being sought from a single site for inclusion in the trial."

Answered by AI

Are researchers currently enrolling participants for this trial?

"Indeed, information available on clinicaltrials.gov shows that this investigation is presently in search of suitable participants. The trial was first made public on April 3rd, 2024 and its latest update also occurred on the same date. A total of 102 individuals will be enrolled from a single site for this study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
Stephen Lownie 2024. "The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229483.
~68 spots leftby Dec 2027
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