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Completed

NCT Number: NCT05832450

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Universidad de Navarra

Pamplona, Navarre, 31160, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Red cell concentrate transfusion

Other

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

Primary outcomes

  1. Number of red cell concentrate transfused

    Time frame: During the surgery

    Number of red cell concentrate transfused

  2. Number of red cell concentrate transfused

    Time frame: Immediately (first 24 hours) after the surgery

    Number of red cell concentrate transfused

Secondary outcomes

  1. Concentration of hemoglobine

    Time frame: Pre-surgery

    Concentration of pre-surgery hemoglobine

  2. Brain tumor volume

    Time frame: Pre-surgery

    Brain tumor volume (mm3) on preoperative MRI

  3. Number of patients with previous tumor craniotomy

    Time frame: Pre-surgery

    Number of patients with previous tumor craniotomy at the same place

  4. Number of craniotomies

    Time frame: During the surgery

    Number of craniotomies

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Hospital Clinic of Barcelona
  • 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
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital de Cruces
  • Hospital de Leon
  • Hospital del Mar
  • Parc Taulí Hospital Universitari
  • University of Salamanca

Registry information

Official study title

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

Acronym: TScoreBTR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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