Clinical trial NCT05832450: Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)
Official title: Validation of a Predictive Model to Calculate the Risk of Red Blood Cells Concentrates Transfusion in Patients Undergoing Elective Brain Tumours Resections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor Adult
Transfusion
Surgery
Keywords: Predictive model
Risk of red blood cells concentrates transfusion
Brain tumours resections (primary or metastatic)
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: University of Salamanca
name: Hospital de Leon
name: Parc Taulí Hospital Universitari
name: Hospital de Cruces
name: Hospital del Mar
name: Hospital Universitario Marqués de Valdecilla
name: Hospital Universitario Central de Asturias
name: Hospital Son Espases
name: Hospital Universitario Virgen de la Arrixaca
name: Hospital General Universitario de Valencia
name: Hospital Universitari de Bellvitge
name: Hospital Miguel Servet
First posted: 2023-04-27
Enrollment: 1434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing craniotomy for elective brain tumour resection (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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of red cell concentrate transfused
timeFrame: During the surgery
measure: Number of red cell concentrate transfused
timeFrame: Immediately (first 24 hours) after the surgery
Secondary outcomes:
measure: Concentration of hemoglobine
timeFrame: Pre-surgery
measure: Brain tumor volume
timeFrame: Pre-surgery
measure: Number of patients with previous tumor craniotomy
timeFrame: Pre-surgery
measure: Number of craniotomies
timeFrame: During the surgery
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Department of Perioperative Medicine and Intensive Care
name: Martinez-Simon Antonio, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.