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PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Brain Tumors, Neoplasms, Gliomas, Astrocytomas, Meningiomas

Thank you

Trial Information

PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS


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.


Inclusion Criteria:



- Patients who agree to participate by giving informed consent

- Eligible previously untreated patients with resectable brain tumor.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of patients with need of blood transfusion.

Outcome Description:

(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)

Outcome Time Frame:

24-48 hours

Safety Issue:

Yes

Principal Investigator

Randy O Guerra, MD

Investigator Role:

Study Director

Investigator Affiliation:

Colombian foundation center for epilepsy and neurological disease - FIRE

Authority:

Colombia:INVIMA

Study ID:

NCT28072012FIRE

NCT ID:

NCT01655927

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Brain Tumors
  • Neoplasms
  • Gliomas
  • Astrocytomas
  • Meningiomas
  • Neoplasms
  • Tranexamic Acid
  • Brain Tumors
  • Astrocytoma
  • Brain Neoplasms
  • Neoplasms
  • Glioma
  • Meningioma

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