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

March 13, 2024 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martinez-Simon Antonio, PhD, MD
  • Phone Number: 4813 +34948255400
  • Email: amartinezs@unav.es

Study Contact Backup

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31160
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing craniotomy for elective brain tumour resection (primary or metastatic).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of red cell concentrate transfused
Time Frame: During the surgery
Number of red cell concentrate transfused
During the surgery
Number of red cell concentrate transfused
Time Frame: Immediately (first 24 hours) after the surgery
Number of red cell concentrate transfused
Immediately (first 24 hours) after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of hemoglobine
Time Frame: Pre-surgery
Concentration of pre-surgery hemoglobine
Pre-surgery
Brain tumor volume
Time Frame: Pre-surgery
Brain tumor volume (mm3) on preoperative MRI
Pre-surgery
Number of patients with previous tumor craniotomy
Time Frame: Pre-surgery
Number of patients with previous tumor craniotomy at the same place
Pre-surgery
Number of craniotomies
Time Frame: During the surgery
Number of craniotomies
During the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

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

Investigators

  • Principal Investigator: Martinez-Simon Antonio, PhD, MD, Department of Perioperative Medicine and Intensive Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2021

Primary Completion (Actual)

February 29, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TScoreBTR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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