Meningioma and Embolism Thrombosis Risk & Investigation o... | NCT06709833

Studies
Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation

NCT06709833

Sponsor

University Hospital Tuebingen

Status

Recruiting

Last Update Posted

Jan 6, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Meningeoma
Thrombembolism
Surgical Resection

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2024Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Aug 31, 2026Estimated

First Submitted Date

Nov 25, 2024

First Submission Date that Met QC Criteria

Nov 25, 2024

First Posted Date

Nov 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2025

Last Update Posted Date

Jan 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with intracranial tumors

meningeoma
glioma (control)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Koeppen, MD	Contact	+4970712986935		michael.koeppen@med.uni-tuebingen.de
Alice Bernard, MD	Contact	+4970712968028		alice.bernard@med.uni-tuebingen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital for Anaesthesiology and Intensive Care Medicine, Tuebingen	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided