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)

September 4, 2026 updated by: Paola Hurtado, Fundacion Clinic per a la Recerca Biomédica
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main hypothesis is Adult patients with glial tumors who present a pattern of hypercoagulability in laboratory parameters and/or thromboelastometry have a higher incidence of thromboembolic events and lower survival compared with patients without a hypercoagulability pattern.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paola Hurtado, MD, PhD
        • Principal Investigator:
          • Javier Bellafont, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboembolic events
Time Frame: 3 months post-surgery
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
Time Frame: first postoperative month
Any thromboembolic events
first postoperative month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Collaborators

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Paola Hurtado Restrepo, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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).

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

September 4, 2026

First Submitted That Met QC Criteria

September 4, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2025/0442 (Other Identifier: FCRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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