NCT06759428

Brief Summary

The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions:

  1. 1.What are the characteristics of patients with CSDH when they are diagnosed?
  2. 2.What treatments do patients with CSDH receive?
  3. 3.What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Oct 2021Jan 2028

Study Start

First participant enrolled

October 1, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

6 years

First QC Date

December 29, 2024

Last Update Submit

January 6, 2025

Conditions

Chronic Subdural HematomaRegistry

Keywords

Chronic subdural hematomaTraumatic Brain InjuryRegistryTreatment outcomeBurr hole drainagemodified Rankin Scale

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale (mRS) score at 3 months following diagnosis

    Functional outcome assessed using the modified Rankin Scale (mRS), a 6-point scale where 0 indicates no symptoms, higher scores reflect greater disability, and 6 represents death.

    3 months following diagnosis

Secondary Outcomes (7)

  • Recurrence rate within 3 months following diagnosis

    3 months following diagnosis

  • Mortality within 3 months following diagnosis

    3 months following diagnosis

  • Complications within 3 months following diagnosis

    3 months following diagnosis

  • Duration of hospital stay

    3 months following diagnosis

  • Markwalder Grading Scale (MGS) score at 3 months following diagnosis

    3 months following diagnosis

  • +2 more secondary outcomes

Study Arms (1)

CSDH patients

All adult patients diagnosed with chronic subdural hematoma who provide informed consent to participate in the study will be included. Participants will receive standard care, with treatment determined by their treating physician based on clinical judgment. Treatment options may include burr hole drainage, craniotomy, embolization of the middle meningeal artery, pharmacological management, or a wait-and-scan approach. Follow-up will be conducted at 3 months via a telephone interview.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with CSDH will be recruited from participating centers.

You may qualify if:

  • Patients diagnosed with CSDH
  • years or older

You may not qualify if:

  • Patients who do not consent to participate in the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Hematoma, Subdural, ChronicBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and InjuriesBrain Injuries

Study Officials

  • Ruben Dammers

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Dagmar Verbaan

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahman Fakhry

CONTACT

+31 10 7043507r.fakhry@erasmusmc.nl

Dana C. Holl

CONTACT

d.holl@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2024

First Posted

January 6, 2025

Study Start

October 1, 2021

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

De-identified research data may be shared with third parties to enhance its scientific value. Requests for data must be submitted to the principal investigators, accompanied by a detailed description of the study's objectives and methods. Data will be available for sharing beginning in January 2028. Sharing will be permitted for scientific purposes, such as individual patient meta-analyses. Additionally, explicit consent will be required for sharing de-identified data outside the European Union.

Time Frame
Data will be available for sharing beginning in January 2028.
Access Criteria
Written proposals will be reviewed by the registry's principal investigators to evaluate their suitability for data use. Before any data is shared, a data-sharing agreement compliant with Dutch regulations will be established.

Locations

NL(2)