An observational study in Brain Tumor Adult, Transfusion and Surgery, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Observational
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.
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 1,434 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing craniotomy for elective brain tumour resection (primary or metastatic).
Exclusion Criteria:
Perioperative data of patient undergoing elective brain tumor resection without requirements of red cell concentrate transfusion.
Other: Red cell concentrate transfusion
Perioperative data of patient undergoing elective brain tumor resection with requirements of red cell concentrate transfusion.
Number of red cell concentrate transfused
Number of red cell concentrate transfused
Time frame: During the surgery
Number of red cell concentrate transfused
Number of red cell concentrate transfused
Time frame: Immediately (first 24 hours) after the surgery
Concentration of hemoglobine
Concentration of pre-surgery hemoglobine
Time frame: Pre-surgery
Brain tumor volume
Brain tumor volume (mm3) on preoperative MRI
Time frame: Pre-surgery
Number of patients with previous tumor craniotomy
Number of patients with previous tumor craniotomy at the same place
Time frame: Pre-surgery
Number of craniotomies
Number of craniotomies
Time frame: During the surgery
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clinica Universidad de Navarra, Universidad de Navarra