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Procedure

Middle Meningeal Artery Embolization for Subdural Hematoma (DAMMET Trial)

N/A

Waitlist Available

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-procedure

Awards & highlights

DAMMET Trial Summary

This trial is testing a new way to treat chronic subdural hematomas (cSDH), which are a type of bleeding in the head. The new approach blocks the blood supply to the tissue that produces the repeated bleeding. The goal of the trial is to see if this helps the cSDH resolve and improves patient outcomes.

Who is the study for?

This trial is for adults with chronic subdural hematomas (cSDH) larger than 7mm and covering more than half of the brain's convexity. Participants must be able to consent or have a surrogate who can. It excludes those with cSDH due to other conditions, life expectancy under 6 months, risky vascular anatomy, or inability to attend follow-ups.Check my eligibility

What is being tested?

The DaMMET study is testing if embolization of the Middle Meningeal Artery (MMA), which blocks blood supply to areas causing repeated bleeding in cSDH patients, is more effective compared to standard surgical treatments that drain the hematoma.See study design

What are the potential side effects?

Potential side effects may include complications from catheter use during embolization such as local bleeding or infection, allergic reactions to materials used for artery blockage, and risks associated with reduced blood flow in treated areas.

DAMMET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

DAMMET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Radiographic resolution of hematoma

Secondary outcome measures

NIH Stroke Scale

Symptomatic improvement

DAMMET Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Symptomatic, MMA embolization + standard of careExperimental Treatment2 Interventions

Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Symptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).

Group II: Asymptomatic, standard of care + MMA embolizationExperimental Treatment2 Interventions

Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Asymptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).

Group III: Symptomatic, standard of careActive Control1 Intervention

Patients in this group will be offered all procedures and care deemed appropriate by the Neurosurgeon in charge of their care. This could include surgical intervention, observation, medical management.

Group IV: Asymptomatic, standard of careActive Control1 Intervention

Patients in this group will be offered all procedures deemed appropriate by the Neurosurgeon in charge of their care. This could include surgical intervention, observation, medical management.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Embolization of the Middle Meningeal Artery

2020

N/A

~40

Standard of care including possible surgical evacuation of subdural hematoma

2020

N/A

~40

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

526 Previous Clinical Trials

2,541,222 Total Patients Enrolled

Media Library

Embolization of the Middle Meningeal Artery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04270955 — N/A

Subdural Hematoma Research Study Groups: Symptomatic, standard of care, Symptomatic, MMA embolization + standard of care, Asymptomatic, standard of care + MMA embolization, Asymptomatic, standard of care

Subdural Hematoma Clinical Trial 2023: Embolization of the Middle Meningeal Artery Highlights & Side Effects. Trial Name: NCT04270955 — N/A

Embolization of the Middle Meningeal Artery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04270955 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are actively engaging in this research study?

"Indeed, the research located on clinicaltrials.gov affirms that this study is currently seeking volunteers. It was first published on March 11th 2020 and last modified on November 2nd 2022. The trial requires 118 participants from a single location to complete it."

Answered by AI

Does this experiment currently accept participants?

"According to clinicaltrials.gov, this trial is in its recruitment phase. It was first advertised on March 11th 2020 and the post has been recently updated as of November 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dartmouth Middle Meningeal Embolization Trial (DaMMET)

Clifford J. Eskey 2020. "Dartmouth Middle Meningeal Embolization Trial (DaMMET)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04270955.