Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 2:07 AM
Study NCT ID:
NCT05832450
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1434}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of red cell concentrate transfused', 'timeFrame': 'During the surgery', 'description': 'Number of red cell concentrate transfused'}, {'measure': 'Number of red cell concentrate transfused', 'timeFrame': 'Immediately (first 24 hours) after the surgery', 'description': 'Number of red cell concentrate transfused'}], 'secondaryOutcomes': [{'measure': 'Concentration of hemoglobine', 'timeFrame': 'Pre-surgery', 'description': 'Concentration of pre-surgery hemoglobine'}, {'measure': 'Brain tumor volume', 'timeFrame': 'Pre-surgery', 'description': 'Brain tumor volume (mm3) on preoperative MRI'}, {'measure': 'Number of patients with previous tumor craniotomy', 'timeFrame': 'Pre-surgery', 'description': 'Number of patients with previous tumor craniotomy at the same place'}, {'measure': 'Number of craniotomies', 'timeFrame': 'During the surgery', 'description': 'Number of craniotomies'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Predictive model', 'Risk of red blood cells concentrates transfusion', 'Brain tumours resections (primary or metastatic)'], 'conditions': ['Brain Tumor Adult', 'Transfusion', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '34393176', 'type': 'BACKGROUND', 'citation': 'Tomas-Biosca A, Martinez-Simon A, Guridi J, Honorato-Cia C, Cacho-Asenjo E, Tejada Solis S, Bejarano B, Becerra-Castro MV, Nunez-Cordoba JM. Development and Performance Evaluation of a Clinical Predictive Model to Estimate the Risk of Red Blood Cell Requirements in Brain Tumor Surgery. J Neurosurg Anesthesiol. 2023 Jan 1;35(1):74-79. doi: 10.1097/ANA.0000000000000793. Epub 2021 Aug 16.'}, {'pmid': '33470594', 'type': 'BACKGROUND', 'citation': 'Tomas-Biosca A, Martinez-Simon A, Guridi J, Tejada Solis S, Bejarano B, Honorato-Cia C, Cacho-Asenjo E, Nunez-Cordoba JM. Preoperative Hemoglobin and Actual Need for Blood Transfusion in Brain Tumor Resection Procedures: A Retrospective Cohort Study. J Neurosurg Anesthesiol. 2022 Apr 1;34(2):251-252. doi: 10.1097/ANA.0000000000000753. No abstract available.'}, {'pmid': '40901795', 'type': 'DERIVED', 'citation': 'Contreras-Lopez L, Clavero FI, Hurtado Restrepo PA, de Arriba NP, Alvarez AD, Montes Armenteros JA, Pellicena MP, Colorado AF, Asensi PD, Candil JF, Garcia LG, Albamonte PS, Krauchi OR, Nunez-Cordoba JM, Martinez-Simon A. Efficiency in packed red blood management for brain tumor resection: multicentre prospective cohort study (TScoreBTR). Blood Transfus. 2025 Aug 28. doi: 10.2450/BloodTransfus.1069. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'To validate a predictive model for the risk of receiving RBCs in this population. This model uses four preoperative values (haemoglobin levels, tumour volume, previous craniotomy in the same spot, and number of craniotomies foreseen). The investigators would like to create an online data collection tool and calculator.', 'detailedDescription': 'Observational study collecting data from different institutions and teams groups in Spain. The investigators aim at validating one model (published in Journal of Neurosurgical Anesthesiology) in different settings and populations to see if it can be accurately used to provide an opportunity to optimize both the patient and the surgical plan as well as to guide perioperative crossmatch and RBC orders.\n\nInclusion criteria - Brain tumour (primary or metastatic) patients undergoing craniotomy for resection.\n\nExclusion criteria Patients younger than 18 years old. Urgent/emergent surgery. Brain tumours not requiring full craniotomy. Patients with blood conditions causing coagulation abnormalities. Systemic disease associated with significant abnormalities in coagulation times (prothrombin time \\<60% or activated thromboplastin time \\> 50 sg).\n\nOutcome The investigators aim at developing objective and simple criteria about the probability of requirements RBCs during a brain tumour resection surgery. This way we could create a simple tool that would help to optimize both the patient and the surgical plan as well as to guide perioperative crossmatch and RBCs orders.\n\nStatistical Analysis\n\nTransfusion requirement predictive probability will be calculated as follows:\n\n〖1/(1+e〗\\^(-(5.7606 + \\[-0.7037\\*(PH in g/dL)+ 0.0103\\*(BTLTV in mm3)+ 1.0558\\*(NC)+ 0.6232\\*(PC)\\]))) PH: Preoperative haemoglobin; BTLTV: brain tumour lesions total volume; NC: craniotomies number; PC: previous craniotomy. NT=1 if NT\\>1, or 0; PC=1 if PC at the same site for resection (not only biopsy), or 0. Model discrimination and calibration will be assessed with area under ROC curve, and Hosmer-Lemeshow test with calibration plot, respectively. P\\<0.05 will indicate statistical significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing craniotomy for elective brain tumour resection (primary or metastatic).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Brain tumour (primary or metastatic) patients undergoing craniotomy for resection.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.\n* Urgent/emergent surgery.\n* Brain tumours not requiring full craniotomy.\n* Patients with blood conditions causing coagulation abnormalities.\n* Systemic disease associated with significant abnormalities in coagulation times (prothrombin time \\<60% or activated thromboplastin time \\> 50 sg).'}, 'identificationModule': {'nctId': 'NCT05832450', 'acronym': 'TScoreBTR', 'briefTitle': 'Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Validation of a Predictive Model to Calculate the Risk of Red Blood Cells Concentrates Transfusion in Patients Undergoing Elective Brain Tumours Resections', 'orgStudyIdInfo': {'id': 'TScoreBTR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No intervention', 'description': 'Perioperative data of patient undergoing elective brain tumor resection without requirements of red cell concentrate transfusion.', 'interventionNames': ['Other: Red cell concentrate transfusion']}], 'interventions': [{'name': 'Red cell concentrate transfusion', 'type': 'OTHER', 'description': 'Perioperative data of patient undergoing elective brain tumor resection with requirements of red cell concentrate transfusion.', 'armGroupLabels': ['No intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31160', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clínica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Martinez-Simon Antonio, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Perioperative Medicine and Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'University of Salamanca', 'class': 'OTHER'}, {'name': 'Hospital de Leon', 'class': 'OTHER_GOV'}, {'name': 'Parc Taulí Hospital Universitari', 'class': 'OTHER'}, {'name': 'Hospital de Cruces', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Hospital Universitario Marqués de Valdecilla', 'class': 'OTHER'}, {'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}, {'name': 'Hospital Son Espases', 'class': 'OTHER'}, {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}, {'name': 'Hospital General Universitario de Valencia', 'class': 'OTHER'}, {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, {'name': 'Hospital Miguel Servet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}