Clínica Universidad de Navarra
Pamplona, Navarre, 31160, Spain
NCT Number: NCT05832450
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.
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Notify Me18 year and older
All sexes
Observational
Pamplona, Navarre, 31160, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Perioperative data of patient undergoing elective brain tumor resection with requirements of red cell concentrate transfusion.
Time frame: During the surgery
Number of red cell concentrate transfused
Time frame: Immediately (first 24 hours) after the surgery
Number of red cell concentrate transfused
Time frame: Pre-surgery
Concentration of pre-surgery hemoglobine
Time frame: Pre-surgery
Brain tumor volume (mm3) on preoperative MRI
Time frame: Pre-surgery
Number of patients with previous tumor craniotomy at the same place
Time frame: During the surgery
Number of craniotomies
Clinica Universidad de Navarra, Universidad de Navarra
Other
Validation of a Predictive Model to Calculate the Risk of Red Blood Cells Concentrates Transfusion in Patients Undergoing Elective Brain Tumours Resections
Acronym: TScoreBTR
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