Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01655927
Status:
UNKNOWN
Last Update Posted:
2012-08-02
First Post:
2012-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Tranexamic Acid in Brain Tumor Resections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with need of blood transfusion.', 'timeFrame': '24-48 hours', 'description': '(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neoplasms', 'Tranexamic Acid', 'Brain Tumors'], 'conditions': ['Brain Tumors', 'Neoplasms', 'Gliomas', 'Astrocytomas', 'Meningiomas']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTranexamic 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who agree to participate by giving informed consent\n* Eligible previously untreated patients with resectable brain tumor.\n\nExclusion Criteria:\n\n* Patients with previous thromboembolic events.\n* Patients with coagulopathy or anticoagulation therapy. (Abnormal PT, PTT)\n* Patients with impaired renal function (Creatinine \\>1.1mg/dl)\n* Patients with known contraindications to fibrinolytic treatment.\n* Patients receiving rejection therapy.\n* Patients with abnormal liver function.\n* Known allergies to Tranexamic Acid.'}, 'identificationModule': {'nctId': 'NCT01655927', 'acronym': 'COLFIRE', 'briefTitle': 'Efficacy of Tranexamic Acid in Brain Tumor Resections', 'organization': {'class': 'OTHER', 'fullName': 'Colombian Foundation for Epilepsy and Neurological Disease'}, 'officialTitle': 'PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS', 'orgStudyIdInfo': {'id': 'NCT28072012FIRE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid', 'description': '15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline (Placebo)', 'description': '15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory', 'interventionNames': ['Drug: Placebo: Saline']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'armGroupLabels': ['Tranexamic Acid']}, {'name': 'Placebo: Saline', 'type': 'DRUG', 'armGroupLabels': ['Saline (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '604', 'city': 'Cartagena', 'state': 'Departamento de Bolívar', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Randy Guerra, MD', 'role': 'CONTACT', 'email': 'dr.randyguerra@gmail.com', 'phone': '575-6816577', 'phoneExt': '146'}, {'name': 'Fredy Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Randy Guerra, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Colombian foundation center for epilepsy and neurological disease', 'geoPoint': {'lat': 10.39817, 'lon': -75.49328}}], 'centralContacts': [{'name': 'Randy Guerra, MD', 'role': 'CONTACT', 'email': 'dr.randyguerra@gmail.com', 'phone': '575-6816577', 'phoneExt': '146'}], 'overallOfficials': [{'name': 'Randy O Guerra, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Colombian foundation center for epilepsy and neurological disease - FIRE'}, {'name': 'Fredy Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colombian foundation center for epilepsy and neurological disease -FIRE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colombian Foundation for Epilepsy and Neurological Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}