Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation

NCT06709833 | Recruiting

• 1 other identifier: 001_2024_BO2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningeoma; Thrombembolism; Surgical Resection

Keywords

meningeoma; thrombembolism; tissue-factor

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intracranial tumors 1. meningeoma 2. glioma (control)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital for Anaesthesiology and Intensive Care Medicine, Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

Central Study Contacts

Michael Koeppen, MD

CONTACT

+4970712986935; michael.koeppen@med.uni-tuebingen.de

Alice Bernard, MD

CONTACT

+4970712968028; alice.bernard@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: December 16, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)