Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy (EMBRACE Study)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhejiang Provincial People's Hospital

About this trial

To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1)Age > 18 years old; (2)Onset of stroke to hospital admission < 24 hours; (3)Admission with a head CT scan ruling out hemorrhage; (4)Patients undergoing CT perfusion scan before treatment; (5)Confirmation of internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion or tandem occlusion by Digital Subtraction Angiography (DSA) and subsequent EVT; (6)complete 3-months follow-up.

Disqualifiers

(1)Poor quality of preoperative CT perfusion imaging; (2)Posterior circulation occlusion or isolated anterior cerebral artery occlusion; (3)Presence of other severe diseases such as malignant tumors, severe organ failure, or other life-threatening conditions with an expected survival period of less than 90 days; (4)Incomplete imaging and clinical data.

Trial population

The study is a multicenter, prospective, observational clinical registry study, commenced on April 1, 2024, and is expected to end in June 2027. Participants were ALVOS patients undergoing EVT treatment in neurology departments from multiple stroke centers. The data from Zhejiang Provincial People's Hospital compose the model training cohort, while data from other centers serve as an independent external validation cohort. The protocol of the study has been approved by the human Ethics Committee of Zhejiang Provincial People's Hospital (KY2024058). All clinical investigations will be conducted according to the principles set in the Declaration of the Helsinki.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The occurrence of MBE

Patients developed MBE within 3 days post-EVT

Time frame
3 days post-EVT

Secondary outcomes

1

90 days mRS score

The follow-up mRS scores of enrolled patients at 90 days after EVT.

Time frame
90 days after EVT
2

PH

Evidence of parenchymal hemorrhage (PH type) on cranial imaging at 3-5 days after EVT

Time frame
3-5 days after EVT

Other outcomes

Sponsors and contacts

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