Usefulness of Thromboelastography as a Predictor of Prognosis in Patients Undergoing Surgery for Glial Tumors and of the Risk of Postoperative Thromboembolic Disease (GliTEM)
GliTEM
1 other identifier
observational
100
1 country
1
Brief Summary
The objective of our study is to investigate the clinical significance of thromboelastometric values in the development of thrombotic events and survival in patients with glial tumors, to reduce thromboembolic complications and optimize oncological treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2026
CompletedFirst Submitted
Initial submission to the registry
September 4, 2026
CompletedFirst Posted
Study publicly available on registry
September 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
September 10, 2026
September 1, 2026
1 year
September 4, 2026
September 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Thromboembolic events
Any newly developed thrombotic event (or acute worsening of a previous one) occurring within: Pulmonary embolism, stroke, venous trombosis
3 months post-surgery
Thromboembolic events
Any thromboembolic events
first postoperative month
Interventions
* Molecular markers: including Next-Generation Sequencing (Oncomine Comprehensive Assay v3 or Oncomine Precision Assay) when available. * MGMT promoter methylation status.
Eligibility Criteria
Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent
You may qualify if:
- Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent
You may not qualify if:
- Patients under 18 years of age.
- Emergency surgery.
- Patients receiving antiplatelet or anticoagulant treatment.
- Patients with known hematologic diseases associated with coagulation abnormalities. Examples include:
- Congenital or acquired platelet function disorders.
- Congenital deficiency of protein C or protein S.
- Deficiency of coagulation factors II, V, VII, X, XII.
- Glanzmann thrombasthenia.
- Hemophilia A, B, or C.
- Idiopathic thrombocytopenic purpura (ITP).
- von Willebrand disease (types I, II, and III).
- Systemic diseases that cause significant coagulation time alterations:
- Prothrombin time \< 60%.
- Activated partial thromboplastin time (aPTT) \> 50 seconds.
- Patients with suspected glial or neuroglial tumor in the context of long-standing epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínic Barcelona
Barcelona, 08036, Spain
Related Publications (1)
1. Falanga, A., Schieppati, F. & Russo, D. Cancer Tissue Procoagulant Mechanisms and the Hypercoagulable State of Patients with Cancer. Semin. Thromb. Hemost. 41, 756-764 (2015). 2. Falanga, A., Marchetti, M. & Vignoli, A. Coagulation and cancer: Biological and clinical aspects. J. Thromb. Haemost. 11, 223-233 (2013). 3. Falanga A, Russo L, V. C. Mechanisms of thrombosis in cancer. Thromb Res 131, (2013). 4. Falanga, A. & Marchetti, M. Hemostatic biomarkers in cancer progression. Thromb. Res. 164, S54-S61 (2018). 5. Falanga, A. et al. Hypercoagulation screening as an innovative tool for risk assessment, early diagnosis and prognosis in cancer: The HYPERCAN study. Thromb. Res. 140, S55-S59 (2016). 6. Marchetti, M. et al. Thrombin generation predicts early recurrence in breast cancer patients. J. Thromb. Haemost. 18, 2220-2231 (2020). 7. Falanga A, Schieppati F, R. L. Pathophysiology 1. Mechanisms of Thrombosis in Cancer Patients. Cancer Treat Res 179, 11-36 (2019). 8. Giaccherini, C. et al. Thrombotic biomarkers for risk prediction of malignant disease recurrence in patients with early stage breast cancer. Haematologica 105, 1704-1711 (2020). 9. Streiff MB, Ye X, Kickler TS, Desideri S, Jani J, Fisher J, G. S. A prospective multicenter study of venous thromboembolism in patients with newly-diagnosed high-grade glioma: hazard rate and risk factors. J Neurooncol 124, 299-305 (2015). 10. Edwin, N. C. et al. Recurrent venous thromboembolism in glioblastoma. Thromb. Res. 137, 184-188 (2016). 11. Brandes, A. A. et al. Incidence and risk of thromboembolism during treatment of high-grade gliomas: A prospective study. Eur. J. Cancer 33, 1592-1596 (1997). 12. Chiocca, E. A. & Schwartzbaum, J. A. Gliomas and venous thromboembolism: How common? J. Neurosurg. 106, 599-600 (2007). 13. Semrad, T. J. et al. Epidemiology of venous thromboembolism in 9489 patients with malignant glioma. J. Neurosurg. 106, 601-608 (2007).
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paola Hurtado Restrepo, MD, PhD
Hospital Clinic of Barcelona
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 4, 2026
First Posted
September 10, 2026
Study Start
May 30, 2026
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
September 10, 2026
Record last verified: 2026-09