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RecruitingNCT07813377GliTEMUpdated Sep 10, 2026

Usefulness of Thromboelastography as a Predictor of Prognosis in Patients Undergoing Surgery for Glial Tumors and of the Risk of Postoperative Thromboembolic Disease (GliTEM)

An observational study in Glial Tumors, Thrombosis and Pulmonary Embolism (Diagnosis), sponsored by Fundacion Clinic per a la Recerca Biomédica. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Fundacion Clinic per a la Recerca Biomédica · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Glial Tumors
  • Thrombosis
  • Pulmonary Embolism (Diagnosis)

Keywords

  • Glial tumors
  • Thrombosis
  • thromboelastometry
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In context

Glioma

1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 273 observational studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica is the lead sponsor of 64 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing surgical excision or with a diagnostic impression of glial tumor who provide written

Exclusion criteria

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 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:

    • \< 60%.
    • Activated partial thromboplastin time (aPTT) > 50 seconds.
  • Patients with suspected glial or neuroglial tumor in the context of long-standing epilepsy
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testThromboelastometry values: EXTEM CT, MCF, α-angle below the lower limit of normal. Measurement obtained after anesthetic induction. - PT, aPTT, fibrinogen, platelet count. - Thrombin generation. -

    * Molecular markers: including Next-Generation Sequencing (Oncomine Comprehensive Assay v3 or Oncomine Precision Assay) when available. * MGMT promoter methylation status.

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What researchers measure

Primary outcomes

  1. Thromboembolic events

    Any newly developed thrombotic event (or acute worsening of a previous one) occurring within: Pulmonary embolism, stroke, venous trombosis

    Time frame: 3 months post-surgery

  2. Thromboembolic events

    Any thromboembolic events

    Time frame: first postoperative month

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Study locations

1 of 1 sites recruiting
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References and documents

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).

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.

Of 113 non-industry observational studies under Glioma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 104. This study's planned 12 months is below that.

Counting every sponsor, half of 123 studies reached it within 60 months; a quarter within 29 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 10, 2026
StartActual
May 30, 2026
Primary completionEst.
May 30, 2027
CompletionEst.
May 30, 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07813377
Lead sponsor
Fundacion Clinic per a la Recerca Biomédica
Responsible party
Paola Hurtado (MD, PhD, Hospital Clinic of Barcelona) — Principal investigator
First posted
Sep 10, 2026
Start date
May 30, 2026
Primary completion
May 30, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Paola A Hurtado, MD, PhD
Contact
phurtado@clinic.cat
34 932275558
Paola Hurtado Restrepo, MD, PhD
principal investigator · Hospital Clinic of Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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