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Trial Title:
Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)
NCT ID:
NCT05832450
Condition:
Brain Tumor Adult
Transfusion
Surgery
Conditions: Official terms:
Brain Neoplasms
Conditions: Keywords:
Predictive model
Risk of red blood cells concentrates transfusion
Brain tumours resections (primary or metastatic)
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Red cell concentrate transfusion
Description:
Perioperative data of patient undergoing elective brain tumor resection with requirements
of red cell concentrate transfusion.
Arm group label:
No intervention
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.
Criteria for eligibility:
Study pop:
Patients undergoing craniotomy for elective brain tumour resection (primary or
metastatic).
Sampling method:
Probability Sample
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clínica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31160
Country:
Spain
Start date:
March 21, 2021
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Clinica Universidad de Navarra, Universidad de Navarra
Agency class:
Other
Collaborator:
Agency:
Hospital Clinic of Barcelona
Agency class:
Other
Collaborator:
Agency:
University of Salamanca
Agency class:
Other
Collaborator:
Agency:
Hospital de Leon
Agency class:
Other
Collaborator:
Agency:
Parc Taulí Hospital Universitari
Agency class:
Other
Collaborator:
Agency:
Hospital de Cruces
Agency class:
Other
Collaborator:
Agency:
Hospital del Mar
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Marqués de Valdecilla
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Central de Asturias
Agency class:
Other
Collaborator:
Agency:
Hospital Son Espases
Agency class:
Other
Collaborator:
Agency:
Hospital Clínico Universitario Virgen de la Arrixaca
Agency class:
Other
Collaborator:
Agency:
Hospital General Universitario de Valencia
Agency class:
Other
Collaborator:
Agency:
Hospital Universitari de Bellvitge
Agency class:
Other
Collaborator:
Agency:
Hospital Miguel Servet
Agency class:
Other
Source:
Clinica Universidad de Navarra, Universidad de Navarra
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832450
