Brain TumorsPhase 3COLFIRENCT01655927
Efficacy of Tranexamic Acid in Brain Tumor Resections
A Phase 3 study testing Tranexamic Acid in people with Brain Tumors and Neoplasms, run by Colombian Foundation for Epilepsy and Neurological Disease at 1 site in Colombia.
Trial summary
The purpose of this study is to determine whether Tranexamic Acid is effective or not in the reduction of intraoperative bleeding loss in brain tumors resections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Tumors, Neoplasms, Gliomas
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2012to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agree to participate by giving informed consent
- Eligible previously untreated patients with resectable brain tumor.
Who cannot join
- Patients with previous thromboembolic events.
- Patients with coagulopathy or anticoagulation therapy. (Abnormal PT, PTT)
- Patients with impaired renal function (Creatinine >1.1mg/dl)
- Patients with known contraindications to fibrinolytic treatment.
- Patients receiving rejection therapy.
- Patients with abnormal liver function.
- Known allergies to Tranexamic Acid.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Colombian foundation center for epilepsy and neurological disease
Cartagena, Departamento de Bolívar, 604
Randy Guerra, MD, 575-6816577 ext. 146, dr.randyguerra@gmail.com
Fredy Diaz, MD
About this study
Official title: PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS
The purpose of this study is to determine whether Tranexamic Acid is effective or not in the reduction of intraoperative bleeding loss in brain tumors resections.
Read the detailed description
Brain tumor resection has been associated with increased blood loss and a significant increase in the incidence of Intravascular disseminated coagulopathy. The development of coagulopathy in the context of tumor resection is associated with poor results. Transfusion decision during the course of neurosurgical surgery offers benefits such as increased oxygen carrying capacity but may increase the risk associated with transfusions such as blood infections, hemolysis, lung injury and immunosuppression. The information available on tranexamic acid used in neurosurgery is little, therefore this opens up new alternatives in the techniques of reducing intraoperative bleeding.
Tranexamic acid is an antifibrinolytic agent that blocks the binding of plasminogen to the fibrin surface. It has been used to reduce blood loss during coronary revascularization, liver resection, obstetrics and orthopedic procedures. Tranexamic acid intraoperatively has been shown to reduce blood loss up to 45%. The primary concern when administering an antifibrinolytic drug is the potential increased incidence of thromboembolic events. There is no actual data on the utility of tranexamic acid to reduce blood loss in brain tumors resection surgery.
We want to compare Tranexamic Acid to Saline solution(Placebo) to see whether Tranexamic ACid Administration will reduce blood loss during brain tumor resection. Reduction in transfusion requirements will lead to reduced costs and possible reduction in complications of blood transfusion and perioperative incidents.
- Conditions
- Brain Tumors, Neoplasms, Gliomas, Astrocytomas, Meningiomas
- Being tested
- Tranexamic Acid, Placebo: Saline
- Keywords
- Neoplasms, Tranexamic Acid, Brain Tumors
- Medical subject headings
- Brain Neoplasms, Neoplasms, Glioma, Astrocytoma, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Placebo: SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | 15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory Receives: Drug: Tranexamic Acid |
| Saline (Placebo) | Placebo comparator | 15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory Receives: Drug: Placebo: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with need of blood transfusion.
(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colombian Foundation for Epilepsy and Neurological Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randy O Guerra, MD, Study director, Colombian foundation center for epilepsy and neurological disease - FIREFredy Diaz, MD, Principal investigator, Colombian foundation center for epilepsy and neurological disease -FIRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655927
- Sponsor's protocol ID
- NCT28072012FIRE
- Acronym
- COLFIRE
- Status last verified
- Jul 2012
- First submitted
- 30 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS
- ClinicalTrials.gov ID
- NCT01655927
- Acronym / sponsor ID
- COLFIRE / NCT28072012FIRE
- Conditions
- Brain Tumors, Neoplasms, Gliomas, Astrocytomas, Meningiomas
- Keywords
- Neoplasms, Tranexamic Acid, Brain Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Colombian Foundation for Epilepsy and Neurological DiseaseUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- First posted
- 2 Aug 2012 (estimated)
- 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.
The purpose of this study is to determine whether Tranexamic Acid is effective or not in the reduction of intraoperative bleeding loss in brain tumors resections.
Detailed description
Brain tumor resection has been associated with increased blood loss and a significant increase in the incidence of Intravascular disseminated coagulopathy. The development of coagulopathy in the context of tumor resection is associated with poor results. Transfusion decision during the course of neurosurgical surgery offers benefits such as increased oxygen carrying capacity but may increase the risk associated with transfusions such as blood infections, hemolysis, lung injury and immunosuppression. The information available on tranexamic acid used in neurosurgery is little, therefore this opens up new alternatives in the techniques of reducing intraoperative bleeding.
Tranexamic acid is an antifibrinolytic agent that blocks the binding of plasminogen to the fibrin surface. It has been used to reduce blood loss during coronary revascularization, liver resection, obstetrics and orthopedic procedures. Tranexamic acid intraoperatively has been shown to reduce blood loss up to 45%. The primary concern when administering an antifibrinolytic drug is the potential increased incidence of thromboembolic events. There is no actual data on the utility of tranexamic acid to reduce blood loss in brain tumors resection surgery.
We want to compare Tranexamic Acid to Saline solution(Placebo) to see whether Tranexamic ACid Administration will reduce blood loss during brain tumor resection. Reduction in transfusion requirements will lead to reduced costs and possible reduction in complications of blood transfusion and perioperative incidents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic Acid15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory |
| Saline (Placebo) | Placebo comparator | Drug: Placebo: Saline15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who agree to participate by giving informed consent
- Eligible previously untreated patients with resectable brain tumor.
Key exclusion criteria (7 listed)
- Patients with previous thromboembolic events.
- Patients with coagulopathy or anticoagulation therapy. (Abnormal PT, PTT)
- Patients with impaired renal function (Creatinine >1.1mg/dl)
- Patients with known contraindications to fibrinolytic treatment.
- Patients receiving rejection therapy.
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 | Drug | Tranexamic Acid |
| Placebo: Saline | Drug | Saline (Placebo) |
Primary outcome
Number of patients with need of blood transfusion.
Time frame: 24-48 hours
(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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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. This study is not recruiting at the moment.
Randy O Guerra, MD study director
Colombian foundation center for epilepsy and neurological disease - FIRE
Fredy Diaz, MD principal investigator
Colombian foundation center for epilepsy and neurological disease -FIRE
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 in people with Brain Tumors and Neoplasms, run by Colombian Foundation for Epilepsy and Neurological Disease at 1 site in Colombia.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Aug 2012. 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 Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randy Guerra, MD (575-6816577 ext. 146, dr.randyguerra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with need of blood transfusion. (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2012.