Glial TumorsGliTEMNCT07813377
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 of Glial Tumors and Thrombosis, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glial Tumors, Thrombosis, Pulmonary Embolism (Diagnosis)
- What is being tested?
- 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. -
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent
Who may be able to join
- Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic Barcelona
Barcelona, 08036
Paola Hurtado, MD, PhD, +34932275558 ext. 5558, phurtado@clinic.cat
Javier Bellafont, MD, +34932275558 ext. 5558, fbellafont@clinic.cat
About this study
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.
- Conditions
- Glial Tumors, Thrombosis, Pulmonary Embolism (Diagnosis)
- Being tested
- 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. -
- Keywords
- Glial tumors, Thrombosis, thromboelastometry
- Medical subject headings
- Glioma, Thrombosis, Pulmonary Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
- Molecular markers: including Next-Generation Sequencing (Oncomine Comprehensive Assay v3 or Oncomine Precision Assay) when available.
- MGMT promoter methylation status.
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic events
Any newly developed thrombotic event (or acute worsening of a previous one) occurring within: Pulmonary embolism, stroke, venous trombosis
Measured: 3 months post-surgery
Thromboembolic events
Any thromboembolic events
Measured: first postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start30 May 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glial TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Paola Hurtado, Hospital Clinic of Barcelona
- Investigators
- Paola Hurtado Restrepo, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813377
- Sponsor's protocol ID
- HCB/2025/0442
- Other IDs
- HCB/2025/0442
- Acronym
- GliTEM
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Thromboelastography as a Predictor of Prognosis in Patients Undergoing Surgery for Glial Tumors and of the Risk of Postoperative Thromboembolic Disease (GliTEM)
- ClinicalTrials.gov ID
- NCT07813377
- Acronym / sponsor ID
- GliTEM / HCB/2025/0442
- Conditions
- Glial Tumors, Thrombosis, Pulmonary Embolism (Diagnosis)
- Keywords
- Glial tumors, Thrombosis, thromboelastometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 30 May 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent
Key inclusion criteria (1 listed)
- Patients undergoing surgical excision or biopsy with a diagnostic impression of glial tumor who provide written informed consent
Key exclusion criteria (15 listed)
- 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:
- Systemic diseases that cause significant coagulation time alterations:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. -* Molecular markers: including Next-Generation Sequencing (Oncomine Comprehensive Assay v3 or Oncomine Precision Assay) when available. * MGMT promoter methylation status. | Diagnostic test | – |
Primary outcome
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
Thromboembolic events
Time frame: first postoperative month
Any thromboembolic events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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).
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola Hurtado Restrepo, MD, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glial Tumors and Thrombosis, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola A Hurtado, MD, PhD (34 932275558, phurtado@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolic events (time frame: 3 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.