Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)

Surgery Clinical Trial

— TScoreBTR  

Official title:

Validation of a Predictive Model to Calculate the Risk of Red Blood Cells Concentrates Transfusion in Patients Undergoing Elective Brain Tumours Resections

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05832450
• Other study ID #: TScoreBTR
• Status: Active, not recruiting
• Start date: March 21, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2023
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2025
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor Adult
• Surgery
• Transfusion

Intervention

Other:
• Red cell concentrate transfusion
Perioperative data of patient undergoing elective brain tumor resection with requirements of red cell concentrate transfusion.

Locations

Country	Name	City	State
Spain	Clínica Universidad de Navarra	Pamplona	Navarra

Sponsors (14)

Lead Sponsor

Collaborator

Clinica Universidad de Navarra, Universidad de Navarra

Hospital Clinic of Barcelona, Hospital Clínico Universitario Virgen de la Arrixaca, Hospital de Cruces, Hospital de Leon, Hospital del Mar, Hospital General Universitario de Valencia, Hospital Miguel Servet, Hospital Son Espases, Hospital Universitari de Bellvitge, Hospital Universitario Central de Asturias, Hospital Universitario Marqués de Valdecilla, Parc Taulí Hospital Universitari, University of Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Tomas-Biosca A, Martinez-Simon A, Guridi J, Honorato-Cia C, Cacho-Asenjo E, Tejada Solis S, Bejarano B, Becerra-Castro MV, Nunez-Cordoba JM. Development and Performance Evaluation of a Clinical Predictive Model to Estimate the Risk of Red Blood Cell Requi — View Citation

Tomas-Biosca A, Martinez-Simon A, Guridi J, Tejada Solis S, Bejarano B, Honorato-Cia C, Cacho-Asenjo E, Nunez-Cordoba JM. Preoperative Hemoglobin and Actual Need for Blood Transfusion in Brain Tumor Resection Procedures: A Retrospective Cohort Study. J Ne — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of red cell concentrate transfused	Number of red cell concentrate transfused	During the surgery
Primary	Number of red cell concentrate transfused	Number of red cell concentrate transfused	Immediately (first 24 hours) after the surgery
Secondary	Concentration of hemoglobine	Concentration of pre-surgery hemoglobine	Pre-surgery
Secondary	Brain tumor volume	Brain tumor volume (mm3) on preoperative MRI	Pre-surgery
Secondary	Number of patients with previous tumor craniotomy	Number of patients with previous tumor craniotomy at the same place	Pre-surgery
Secondary	Number of craniotomies	Number of craniotomies	During the surgery