Health TrialsbyHealthPanel

Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)

ConditionsSubdural HematomaSubdural Hematoma, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAesculap AG

About this trial

The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years old or older

Confirmed diagnosis of chronic subdural hematoma (CSDH) or recurrent subdural hematoma (SDH)

Completed documented informed consent

Willingness and presumed capability to participate in follow-up visits for up to 6 months (180±30 days)

Disqualifiers

Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment

Need craniotomy

Any sign of anatomical variations that could make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses)

Coagulation dysfunction with INR>1.8 and/or platelet count <80x109 /L

Trial population

A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Histoacryl®

    Device

    Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Recurrence or progression of subdural hematoma

Recurrence will be described as maximum thickness of SDH exceeding 10 mm, recurrence of symptoms or the patient requiring reoperation, meaning a second burr-hole drainage due to SDH. \*\*Progression will be described as maximum thickness of SDH increasing over 3 mm compared to the baseline.

Time frame
within 3 months

Secondary outcomes

1

Efficacy (1. Time)

Time period from symptoms to embolization

Time frame
V1, preoperatively (baseline visit)
2

Efficacy (2. Time)

Time period from burr-hole drainage to embolization

Time frame
V2, surgery (index procedure)
3

Efficacy (3. Time)

Time period from embolization to recurrence

Time frame
6 months
4

Efficacy (4. Hematoma thickness)

Change in hematoma thickness

Time frame
at V4: 3 months and V5: 6 months compared to baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aesculap AG

Lead sponsor

Source ClinicalTrials.gov
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