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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients under 18 years of age.

Emergency surgery.

Patients receiving antiplatelet or anticoagulant treatment.

Congenital or acquired platelet function disorders.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Fundacion Clinic per a la Recerca Biomédica

Lead sponsor

Hospital Clinic of Barcelona

Sponsor institution

Hospital Clinic of Barcelona

Collaborator