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Brain Tumor AdultTScoreBTRNCT05832450

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

An observational study of Brain Tumor Adult and Transfusion, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Tumor Adult, Transfusion, Surgery
What is being tested?
Red cell concentrate transfusion
How many people
1,434 participants
Where
1 siteSpain
Study dates
21 Mar 2021to 29 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Brain tumour (primary or metastatic) patients undergoing craniotomy for resection.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31160

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Red cell concentrate transfusion
Keywords
Predictive model, Risk of red blood cells concentrates transfusion, Brain tumours resections (primary or metastatic)
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Red cell concentrate transfusionOther

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

Study groups in NCT05832450
Study groupRoleWhat they receive
No interventionPerioperative data of patient undergoing elective brain tumor resection without requirements of red cell concentrate transfusion.
Receives: Other: Red cell concentrate transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of red cell concentrate transfused

    Number of red cell concentrate transfused

    Measured: During the surgery

  2. Number of red cell concentrate transfused

    Number of red cell concentrate transfused

    Measured: Immediately (first 24 hours) after the surgery

Secondary outcomes (4)

  1. Concentration of hemoglobine

    Concentration of pre-surgery hemoglobine

    Measured: Pre-surgery

  2. Brain tumor volume

    Brain tumor volume (mm3) on preoperative MRI

    Measured: Pre-surgery

  3. Number of patients with previous tumor craniotomy

    Number of patients with previous tumor craniotomy at the same place

    Measured: Pre-surgery

  4. Number of craniotomies

    Number of craniotomies

    Measured: During the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start21 Mar 2021
  3. Primary completion29 Feb 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832450
Sponsor's protocol ID
TScoreBTR
Acronym
TScoreBTR
Status last verified
Dec 2024
First submitted
9 Dec 2022
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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 Requirements in Brain Tumor Surgery. J Neurosurg Anesthesiol. 2023 Jan 1;35(1):74-79. doi: 10.1097/ANA.0000000000000793. Epub 2021 Aug 16.

    PubMed 34393176

  • 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 Neurosurg Anesthesiol. 2022 Apr 1;34(2):251-252. doi: 10.1097/ANA.0000000000000753. No abstract available.

    PubMed 33470594

  • Contreras-Lopez L, Clavero FI, Hurtado Restrepo PA, de Arriba NP, Alvarez AD, Montes Armenteros JA, Pellicena MP, Colorado AF, Asensi PD, Candil JF, Garcia LG, Albamonte PS, Krauchi OR, Nunez-Cordoba JM, Martinez-Simon A. Efficiency in packed red blood management for brain tumor resection: multicenter prospective cohort study (TScoreBTR). Blood Transfus. 2026 Jan-Feb;24(1):56-64. doi: 10.2450/BloodTransfus.1069. Epub 2025 Aug 28.

    PubMed 40901795

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Tumor Adult and Transfusion, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of red cell concentrate transfused (time frame: During the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05832450, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.

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