Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation (001_2024_BO2)

Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown.

In this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection.

Blood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes.

As a control cohort, blood samples are obtained from patients undergoing resection for glioma.

Study Overview

• Status: Recruiting
• Conditions: Surgical Resection; Meningeoma; Thrombembolism

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Michael Koeppen, MD; Phone Number: +4970712986935; Email: michael.koeppen@med.uni-tuebingen.de
• Study Contact Backup: Name: Alice Bernard, MD; Phone Number: +4970712968028; Email: alice.bernard@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Tuebingen, Baden-Wuerttemberg, Germany, 72076
      • Recruiting
      • University Hospital for Anaesthesiology and Intensive Care Medicine, Tuebingen
      • Contact: Alice Bernard, MD; Phone Number: 0049-7071-2968029; Email: alice.bernard@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with intracranial tumors

1. meningeoma
2. glioma (control)

Description

Inclusion Criteria:

• Patients undergoing resection for meningioma or
• Patients undergoing resection for glioma or
• Healthy controls
• written consent for study participation

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Meningioma resection; patients undergoing resection for meningioma
Glioma resection; Patients undergoing glioma resection as a control cohort for meningioma patients
Healthy controls; Healthy controls without tumor and surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue factor	Concentration of tissue factor at pre-surgery and immediately after tumor resection (during close-up).	duration of surfical tumor resection (a few hours)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: meningeoma; thrombembolism; tissue-factor
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Thrombosis; Embolism; Meningioma; Embolism and Thrombosis
• Other Study ID Numbers: 001_2024_BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No