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Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)

ConditionChronic Subdural Hematoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorJuan M. Ramos Acevedo

About this trial

Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 21

Speak and understand Spanish or English

Resident of Puerto Rico

Glasgow coma scale ≥ 14/15

Disqualifiers

Acute subdural hematoma

Focal, non-hemispheric localization of cSDH

Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging

Imaging evidence of skull fracture over the subdural hematoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Embolization of the middle meningeal artery

    Procedure/Surgery

    Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.

  • Surgical Evacuation via burr hole or craniotomy

    Procedure/Surgery

    The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.

Treatment groups

658 Participants
are divided into 2 treatment groups
Group A: Endovascular EmbolizationExperimental treatment 1 intervention
Group B: Surgical Evacuation of HematomaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reoperation

Number of patients requiring reoperation due to recurrent chronic subdural hematoma.

Time frame
3 months, 6 months, and 12 months

Secondary outcomes

1

Modified Rankin Scale (mRS)

The modified Rankin Scale (mRS) will assess neurological disability. The scale comprises seven levels, from 0 to 6, with higher scores indicating greater disability, and 6 indicating death.

Time frame
Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months
2

Glasgow Coma Scale (GCS)

The Glasgow coma scale (GCS) will assess consciousness level. GCS score can range from 3 (completely unresponsive) to 15 (completely alert and oriented).

Time frame
Pre-operative, 24 hours, 2 weeks
3

Visual Analog Scale (VAS)

The visual analog scale (VAS) will assess pain levels. VAS represents the severity of pain from 0 "no pain" to 10 "very severe pain."

Time frame
Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
4

Quality of life (EQ-5D-5L)

Will be measured with the EuroQol 5 dimensions and 5 levels (EQ-5D-5L) grading scale.

Time frame
Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Juan M. Ramos Acevedo

Lead sponsor

University of Puerto Rico

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: