NCT05832450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,434

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

2.9 years

First QC Date

December 9, 2022

Last Update Submit

December 9, 2024

Conditions

Brain Tumor AdultTransfusionSurgery

Keywords

Predictive modelRisk of red blood cells concentrates transfusionBrain tumours resections (primary or metastatic)

Outcome Measures

Primary Outcomes (2)

  • Number of red cell concentrate transfused

    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

Secondary Outcomes (4)

  • Concentration of hemoglobine

    Pre-surgery

  • Brain tumor volume

    Pre-surgery

  • Number of patients with previous tumor craniotomy

    Pre-surgery

  • Number of craniotomies

    During the surgery

Study Arms (1)

No intervention

Perioperative data of patient undergoing elective brain tumor resection without requirements of red cell concentrate transfusion.

Other: Red cell concentrate transfusion

Interventions

Red cell concentrate transfusionOTHER

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

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Navarre, 31160, Spain

Location

Related Publications (3)

  • 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.

    PMID: 34393176BACKGROUND

  • 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.

    PMID: 33470594BACKGROUND

  • 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: multicentre prospective cohort study (TScoreBTR). Blood Transfus. 2025 Aug 28. doi: 10.2450/BloodTransfus.1069. Online ahead of print.

    PMID: 40901795DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martinez-Simon Antonio, PhD, MD

    Department of Perioperative Medicine and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

April 27, 2023

Study Start

March 21, 2021

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations

ES(1)