Brain TumorPhase 3NCT06229483

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

A Phase 3 study testing TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION in people with Brain Tumor and Bleeding, run by Stephen Lownie at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Brain Tumor, Bleeding
What is being tested?: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 1 siteCanada
Study dates: 3 Apr 2024to 31 Dec 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Exclusion Criteria 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.

Show all 11Show fewer

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 subjects 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stephen Lownie, MD contact

902-473-6449

stephen.lownie@nshealth.ca

Lisa Julien, RN BScN contact

902-473-3877

lisa.julien@nshealth.ca

Canada1 site, 1 recruiting

Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H3A7
Stephen Lownie, MD, 902-473-6449, stephen.lownie@nshealth.ca
Lisa Julien, RN BSCN CCRP, 902-473-3877, lisa.julien@nshealth.ca
Recruiting

Other trials in Canada

About this study

Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA reduce the amount of estimated blood loss during surgery?
Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA prevent re-operation, disability or death related to bleeding inside the head during and after surgery? Participants are randomized to receive 20 mg/kg IV bolus of TXA or matching placebo within 30 minutes of start of surger, and then 1 mg/kg/hr infusion of TXA or matching from the start of surgery to end of surgery. Treatment allocation is blinded. Investigator will compare the two treatment arms to see whether there are differences in the amount of blood loss during surgery and bleeding-related complications. Investigators will also monitor for any side effects of TXA.

Read the detailed description

Excessive blood loss during and after a neurosurgical procedure may increase illness and cause death. The surgeons and their team put in a lot of effort during surgery to and prevent excessive bleeding during and after surgery. One of the medications that may help is tranexamic acid (TXA). TXA is a medication that is widely used in cardiac, orthopedic and trauma surgery to prevent heavy bleeding, the need for blood transfusion and reduce death. During neurosurgery, there is not enough proof whether giving TXA to participants reduces blood loss, and there are no clear guidelines regarding the use of TXA. Investigators are interested in studying the effect of TXA on blood loss in participants undergoing craniotomy to remove a brain tumor. A craniotomy is an operation where a piece of the skull is removed to show part of the brain to remove a brain tumor. One of the risks associated with this procedure is bleeding. Currently, some participants undergoing this type of surgery receive TXA and others do not, as the decision to administer TXA is based on an investigator's preference. Therefore, a study investigating the impact of TXA on bleeding during or following craniotomy, as well as its safety, is needed to better inform practice and potentially improve outcomes of surgery.

Conditions: Brain Tumor, Bleeding
Being tested: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION, Placebo
Medical subject headings: Brain Neoplasms, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTIONDrug
Also called TXA
Tranexamic acid 20 mg/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, for the duration of surgery. Treatment is blinded.
PlaceboOther
Also called Normal saline (0.9% sodium chloride)
0.9% normal saline 20ml/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 ml/kg/hr infusion of 0.9 % sodium chloride for the duration of surgery. Treatment is blinded.

Study groups in NCT06229483
Study group	Role	What they receive
Tranexamic Acid	Experimental	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. Receives: Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
Matching Placebo	Placebo comparator	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. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimated intraoperative blood loss
1. EBL (ml/kg) = ERCV lost (ml)/[weight (kg) x hematocrit preop/100] i. ERCV = EBV x hematocrit/100 ii. ERCV lost = ERCV preop + ERCV transfused - ERCV postop iii. ERCV transfused = PRBC transfused (ml) x hematocrit transfused PRBC/100 iv. EBV = 75 ml/kg x weight (kg) b. abbreviations used: EBL, estimated blood loss; ERCV, estimated red cell volume; EBV, estimated blood volume; PRBC, packed red blood cells
Measured: Surgery
Reoperation or disability or death due to intracranial hemorrhage within 30 days
Measured: 30 days

Secondary outcomes (11)

What is the difference in Hemoglobin level postoperatively as compared to baseline?
Measured: 24 hrs
Number of subjects requiring transfusion of blood products
Measured: 30 days
Volume of transfused packed red blood cell (PRBC) and fresh frozen plasma (FFP)
Measured: 30 days
What is the difference in Intraoperative hemodynamics between subjects?
Measured: Surgery
Length of operation
Measured: Surgery
Length of intensive care unit (ICU)/hospital stay
Measured: 30 days
Medication related risks, including seizure, thromboembolic event
Measured: 30 days
What is the difference in Platelet level postoperatively as compared to baseline?
Measured: 24 hrs
What is the difference in Fibrinogen level postoperatively as compared to baseline?
Measured: 24 hrs
What is the difference in INR/PTT value level postoperatively as compared to baseline?
Measured: 24 hrs
What is the difference in Hematocrit level postoperatively as compared to baseline?
Measured: 24 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 202431 Dec 2028

First posted29 Jan 2024
Study start3 Apr 2024
Primary completion31 Jan 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Brain TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized to receive a 20 mg/kg IV bolus of TXA, or identical volume of placebo 0.9 % NaCl will be administered intravenously push by the anesthesiologist approximately 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
Masking: Single blind
Who is masked: Participant
Enrolment: 102 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06229483
Sponsor's protocol ID: TXA-2024-01
Status last verified: Mar 2026
First submitted: 10 Jan 2024
Last updated: 19 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Rajagopalan V, Chouhan RS, Pandia MP, Lamsal R, Rath GP. Effect of Intraoperative Blood Loss on Perioperative Complications and Neurological Outcome in Adult Patients Undergoing Elective Brain Tumor Surgery. J Neurosci Rural Pract. 2019 Oct;10(4):631-640. doi: 10.1055/s-0039-3399487. Epub 2019 Dec 11.
PubMed 31831982
Rolston JD, Han SJ, Lau CY, Berger MS, Parsa AT. Frequency and predictors of complications in neurological surgery: national trends from 2006 to 2011. J Neurosurg. 2014 Mar;120(3):736-45. doi: 10.3171/2013.10.JNS122419. Epub 2013 Nov 22.
PubMed 24266542
Hooda B, Chouhan RS, Rath GP, Bithal PK, Suri A, Lamsal R. Effect of tranexamic acid on intraoperative blood loss and transfusion requirements in patients undergoing excision of intracranial meningioma. J Clin Neurosci. 2017 Jul;41:132-138. doi: 10.1016/j.jocn.2017.02.053. Epub 2017 Mar 7.
PubMed 28283245
Vel R, Udupi BP, Satya Prakash MV, Adinarayanan S, Mishra S, Babu L. Effect of low dose tranexamic acid on intra-operative blood loss in neurosurgical patients. Saudi J Anaesth. 2015 Jan;9(1):42-8. doi: 10.4103/1658-354X.146304.
PubMed 25558198
Eustache G, Nardi N, Rousseau C, Aouaissia S, Aillet S, Delahaye Larralde S, Wodey E, Riffaud L. Importance of tranexamic acid in pediatric monosutural craniosynostosis surgery. J Neurosurg Pediatr. 2021 Dec 24;29(4):412-418. doi: 10.3171/2021.10.PEDS21438. Print 2022 Apr 1.
PubMed 34952528
Crantford JC, Wood BC, Claiborne JR, Ririe DG, Couture DE, Thompson JT, David LR. Evaluating the safety and efficacy of tranexamic acid administration in pediatric cranial vault reconstruction. J Craniofac Surg. 2015 Jan;26(1):104-7. doi: 10.1097/SCS.0000000000001271.
PubMed 25534062
Wu B, Lu Y, Yu Y, Yue H, Wang J, Chong Y, Cui W. Effect of tranexamic acid on the prognosis of patients with traumatic brain injury undergoing craniotomy: study protocol for a randomised controlled trial. BMJ Open. 2021 Nov 25;11(11):e049839. doi: 10.1136/bmjopen-2021-049839.
PubMed 34824110
CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PubMed 20554319
Brown NJ, Hartke JN, Pacult M, Burkett KR, Gendreau J, Catapano JS, Lawton MT. Tranexamic Acid Demonstrates Efficacy without Increased Risk for Venous Thromboembolic Events in Cranial Neurosurgery: Systematic Review of the Evidence and Current Applications in Nontraumatic Pathologies. World Neurosurg. 2024 Mar;183:29-40. doi: 10.1016/j.wneu.2023.11.148. Epub 2023 Dec 3.
PubMed 38052364

Interested in taking part?

Stephen Lownie, MD

902-473-6449

stephen.lownie@nshealth.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
ClinicalTrials.gov ID: NCT06229483
Acronym / sponsor ID: TXA-2024-01
Conditions: Brain Tumor, Bleeding
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 102 participants (estimated)
Lead sponsor: Stephen LownieUniversity, hospital or other
Collaborators: Dalhousie University
Study start: 3 Apr 2024 (actual)
Primary completion: 31 Jan 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 29 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA reduce the amount of estimated blood loss during surgery?
Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA prevent re-operation, disability or death related to bleeding inside the head during and after surgery? Participants are randomized to receive 20 mg/kg IV bolus of TXA or matching placebo within 30 minutes of start of surger, and then 1 mg/kg/hr infusion of TXA or matching from the start of surgery to end of surgery. Treatment allocation is blinded. Investigator will compare the two treatment arms to see whether there are differences in the amount of blood loss during surgery and bleeding-related complications. Investigators will also monitor for any side effects of TXA.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Participants will be randomized to receive a 20 mg/kg IV bolus of TXA, or identical volume of placebo 0.9 % NaCl will be administered intravenously push by the anesthesiologist approximately 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

Arm	Type	Receives
Tranexamic Acid	Experimental	Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTIONParticipants 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.
Matching Placebo	Placebo comparator	Other: PlaceboParticipants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.
Exclusion Criteria 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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTIONAlso: TXATranexamic acid 20 mg/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, for the duration of surgery. Treatment is blinded.	Drug	Tranexamic Acid
PlaceboAlso: Normal saline (0.9% sodium chloride)0.9% normal saline 20ml/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 ml/kg/hr infusion of 0.9 % sodium chloride for the duration of surgery. Treatment is blinded.	Other	Matching Placebo

Primary outcome

Estimated intraoperative blood loss
Time frame: Surgery
a. EBL (ml/kg) = ERCV lost (ml)/[weight (kg) x hematocrit preop/100] i. ERCV = EBV x hematocrit/100 ii. ERCV lost = ERCV preop + ERCV transfused - ERCV postop iii. ERCV transfused = PRBC transfused (ml) x hematocrit transfused PRBC/100 iv. EBV = 75 ml/kg x weight (kg) b. abbreviations used: EBL, estimated blood loss; ERCV, estimated red cell volume; EBV, estimated blood volume; PRBC, packed red blood cells
Reoperation or disability or death due to intracranial hemorrhage within 30 days
Time frame: 30 days

11 secondary outcomes

What is the difference in Hemoglobin level postoperatively as compared to baseline?
Time frame: 24 hrs
Number of subjects requiring transfusion of blood products
Time frame: 30 days
Volume of transfused packed red blood cell (PRBC) and fresh frozen plasma (FFP)
Time frame: 30 days
What is the difference in Intraoperative hemodynamics between subjects?
Time frame: Surgery
Length of operation
Time frame: Surgery
Length of intensive care unit (ICU)/hospital stay
Time frame: 30 days
Medication related risks, including seizure, thromboembolic event
Time frame: 30 days
What is the difference in Platelet level postoperatively as compared to baseline?
Time frame: 24 hrs
What is the difference in Fibrinogen level postoperatively as compared to baseline?
Time frame: 24 hrs
What is the difference in INR/PTT value level postoperatively as compared to baseline?
Time frame: 24 hrs
What is the difference in Hematocrit level postoperatively as compared to baseline?
Time frame: 24 hrs

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Results publication: PubMed 31831982Rajagopalan V, Chouhan RS, Pandia MP, Lamsal R, Rath GP. Effect of Intraoperative Blood Loss on Perioperative Complications and Neurological Outcome in Adult Patients Undergoing Elective Brain Tumor Surgery. J Neurosci Rural Pract. 2019 Oct;10(4):631-640. doi: 10.1055/s-0039-3399487. Epub 2019 Dec 11.
Results publication: PubMed 24266542Rolston JD, Han SJ, Lau CY, Berger MS, Parsa AT. Frequency and predictors of complications in neurological surgery: national trends from 2006 to 2011. J Neurosurg. 2014 Mar;120(3):736-45. doi: 10.3171/2013.10.JNS122419. Epub 2013 Nov 22.
Results publication: PubMed 28283245Hooda B, Chouhan RS, Rath GP, Bithal PK, Suri A, Lamsal R. Effect of tranexamic acid on intraoperative blood loss and transfusion requirements in patients undergoing excision of intracranial meningioma. J Clin Neurosci. 2017 Jul;41:132-138. doi: 10.1016/j.jocn.2017.02.053. Epub 2017 Mar 7.
Results publication: PubMed 25558198Vel R, Udupi BP, Satya Prakash MV, Adinarayanan S, Mishra S, Babu L. Effect of low dose tranexamic acid on intra-operative blood loss in neurosurgical patients. Saudi J Anaesth. 2015 Jan;9(1):42-8. doi: 10.4103/1658-354X.146304.
Results publication: PubMed 34952528Eustache G, Nardi N, Rousseau C, Aouaissia S, Aillet S, Delahaye Larralde S, Wodey E, Riffaud L. Importance of tranexamic acid in pediatric monosutural craniosynostosis surgery. J Neurosurg Pediatr. 2021 Dec 24;29(4):412-418. doi: 10.3171/2021.10.PEDS21438. Print 2022 Apr 1.
Results publication: PubMed 25534062Crantford JC, Wood BC, Claiborne JR, Ririe DG, Couture DE, Thompson JT, David LR. Evaluating the safety and efficacy of tranexamic acid administration in pediatric cranial vault reconstruction. J Craniofac Surg. 2015 Jan;26(1):104-7. doi: 10.1097/SCS.0000000000001271.
Results publication: PubMed 34824110Wu B, Lu Y, Yu Y, Yue H, Wang J, Chong Y, Cui W. Effect of tranexamic acid on the prognosis of patients with traumatic brain injury undergoing craniotomy: study protocol for a randomised controlled trial. BMJ Open. 2021 Nov 25;11(11):e049839. doi: 10.1136/bmjopen-2021-049839.
Results publication: PubMed 20554319CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
Results publication: PubMed 38052364Brown NJ, Hartke JN, Pacult M, Burkett KR, Gendreau J, Catapano JS, Lawton MT. Tranexamic Acid Demonstrates Efficacy without Increased Risk for Venous Thromboembolic Events in Cranial Neurosurgery: Systematic Review of the Evidence and Current Applications in Nontraumatic Pathologies. World Neurosurg. 2024 Mar;183:29-40. doi: 10.1016/j.wneu.2023.11.148. Epub 2023 Dec 3.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Stephen Lownie, MD contact

902-473-6449

stephen.lownie@nshealth.ca

Lisa Julien, RN BScN contact

902-473-3877

lisa.julien@nshealth.ca

Stephen Lownie, MD principal investigator

Nova Scotia Health Authority- Queen Elizabeth II HSC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION in people with Brain Tumor and Bleeding, run by Stephen Lownie at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephen Lownie, MD (902-473-6449, stephen.lownie@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated intraoperative blood loss (time frame: Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06229483, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.