Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)
- Conditions
- Brain Tumor AdultTransfusionSurgery
- Interventions
- Other: Red cell concentrate transfusion
- Registration Number
- NCT05832450
- Lead Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1434
- Brain tumour (primary or metastatic) patients undergoing craniotomy for resection.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No intervention Red cell concentrate transfusion Perioperative data of patient undergoing elective brain tumor resection without requirements of red cell concentrate transfusion.
- Primary Outcome Measures
Name Time Method Number of red cell concentrate transfused Immediately (first 24 hours) after the surgery Number of red cell concentrate transfused
- Secondary Outcome Measures
Name Time Method Brain tumor volume Pre-surgery Brain tumor volume (mm3) on preoperative MRI
Concentration of hemoglobine Pre-surgery Concentration of pre-surgery hemoglobine
Number of patients with previous tumor craniotomy Pre-surgery Number of patients with previous tumor craniotomy at the same place
Number of craniotomies During the surgery Number of craniotomies
Trial Locations
- Locations (1)
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain