Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)
NCT ID: NCT05832450
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1434 participants
OBSERVATIONAL
2021-03-21
2024-02-29
Brief Summary
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Detailed Description
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Inclusion criteria - Brain tumour (primary or metastatic) patients undergoing craniotomy for resection.
Exclusion 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).
Outcome 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.
Statistical Analysis
Transfusion requirement predictive probability will be calculated as follows:
〖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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No intervention
Perioperative data of patient undergoing elective brain tumor resection without requirements of red cell concentrate transfusion.
Red cell concentrate transfusion
Perioperative data of patient undergoing elective brain tumor resection with requirements of red cell concentrate transfusion.
Interventions
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Red cell concentrate transfusion
Perioperative data of patient undergoing elective brain tumor resection with requirements of red cell concentrate transfusion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
University of Salamanca
OTHER
Hospital de Leon
OTHER_GOV
Parc Taulí Hospital Universitari
OTHER
Hospital de Cruces
OTHER
Hospital del Mar
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Hospital Universitario Central de Asturias
OTHER
Hospital Son Espases
OTHER
Hospital Universitario Virgen de la Arrixaca
OTHER
Hospital General Universitario de Valencia
OTHER
Hospital Universitari de Bellvitge
OTHER
Hospital Miguel Servet
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Principal Investigators
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Martinez-Simon Antonio, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Perioperative Medicine and Intensive Care
Locations
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Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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TScoreBTR
Identifier Type: -
Identifier Source: org_study_id