Clinical trial · Observational
Usefulness of Thromboelastography as a Predictor of Prognosis in Patients Undergoing Surgery for Glial Tumors and of the Risk of Postoperative Thromboembolic Disease (GliTEM)
NCT07813377CI-TRIAL-00126236GliTEMrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glial Tumors | Glioma | ALIAS | 0.90 |
| Pulmonary Embolism (Diagnosis) | — | UNRESOLVED | — |
| Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thromboelastometry values: EXTEM CT, MCF, α-angle below the lower limit of normal. Measurement obtained after anesthetic induction. - PT, aPTT, fibrinogen, platelet count. - Thrombin generation. - | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Thromboembolic events
- timeFrame
- 3 months post-surgery
- description
- Any newly developed thrombotic event (or acute worsening of a previous one) occurring within: Pulmonary embolism, stroke, venous trombosis
- measure
- Thromboembolic events
- timeFrame
- first postoperative month
- description
- Any thromboembolic events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent Exclusion Criteria: * 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
References
Publications (1)
- BACKGROUND1. 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).