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Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)

Validation of a Predictive Model to Calculate the Risk of Red Blood Cells Concentrates Transfusion in Patients Undergoing Elective Brain Tumours Resections

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05832450
Acronym
TScoreBTR
Enrollment
1434
Registered
2023-04-27
Start date
2021-03-21
Completion date
2024-02-29
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor Adult, Surgery, Transfusion

Keywords

Predictive model, Risk of red blood cells concentrates transfusion, Brain tumours resections (primary or metastatic)

Brief summary

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.

Detailed description

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. 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.

Interventions

OTHERRed cell concentrate transfusion

Perioperative data of patient undergoing elective brain tumor resection with requirements of red cell concentrate transfusion.

Sponsors

Hospital Clinic of Barcelona
CollaboratorOTHER
University of Salamanca
CollaboratorOTHER
Hospital de Leon
CollaboratorOTHER_GOV
Parc Taulí Hospital Universitari
CollaboratorOTHER
Hospital de Cruces
CollaboratorOTHER
Hospital del Mar
CollaboratorOTHER
Hospital Universitario Marqués de Valdecilla
CollaboratorOTHER
Hospital Universitario Central de Asturias
CollaboratorOTHER
Hospital Son Espases
CollaboratorOTHER
Hospital Universitario Virgen de la Arrixaca
CollaboratorOTHER
Hospital General Universitario de Valencia
CollaboratorOTHER
Hospital Universitari de Bellvitge
CollaboratorOTHER
Hospital Miguel Servet
CollaboratorOTHER
Clinica Universidad de Navarra, Universidad de Navarra
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of red cell concentrate transfusedDuring the surgeryNumber of red cell concentrate transfused

Secondary

MeasureTime frameDescription
Concentration of hemoglobinePre-surgeryConcentration of pre-surgery hemoglobine
Brain tumor volumePre-surgeryBrain tumor volume (mm3) on preoperative MRI
Number of patients with previous tumor craniotomyPre-surgeryNumber of patients with previous tumor craniotomy at the same place
Number of craniotomiesDuring the surgeryNumber of craniotomies

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026