Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No intervention 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.
|
Outcome Measures
Primary Outcome Measures
- Number of red cell concentrate transfused [During the surgery]
Number of red cell concentrate transfused
- Number of red cell concentrate transfused [Immediately (first 24 hours) after the surgery]
Number of red cell concentrate transfused
Secondary Outcome Measures
- Concentration of hemoglobine [Pre-surgery]
Concentration of pre-surgery hemoglobine
- Brain tumor volume [Pre-surgery]
Brain tumor volume (mm3) on preoperative MRI
- 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
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clínica Universidad de Navarra | Pamplona | Navarra | Spain | 31160 |
Sponsors and Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra
- Hospital Clinic of Barcelona
- University of Salamanca
- Hospital de Leon
- Complejo Hospitalario Universitario de Albacete
- Hospital Parc Taulí, Sabadell
- Hospital de Cruces
- Hospital del Mar
- Hospital Universitario Marqués de Valdecilla
- Hospital Universitario Central de Asturias
- Hospital Son Espases
- Hospital Clínico Universitario Virgen de la Arrixaca
- Hospital General Universitario de Valencia
Investigators
- Principal Investigator: Martinez-Simon Antonio, PhD, MD, Department of Perioperative Medicine and Intensive Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021.019