A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy

Completed

• Conditions: Malignant Cerebral Edema; Acute Ischemic Stroke; Endovascular Thrombectomy; Symptomatic Intracranial Hemorrhage

• Registration Number: NCT06290076
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials.

Detailed Description

Acute ischemic stroke (AIS) accounts for about 80% of all strokes. The focus of AIS treatment is to restore reperfusion of ischemic territory as soon as possible, promote neurological recovery, reduce disability rate and improve long-term survival rate. In recent years, a series of randomized clinical trials have proved that endovascular thrombectomy (EVT) is safe and effective in the treatment of anterior circulation AIS. EVT has been recommend as the first-line treatment for anterior circulation large vessel occlusion (LVO) stroke by guidelines.

Symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE) are the two most common severe neurological complications, leading to brain tissue hypoxia and neurological dysfunction. Currently, there is a lack of prediction system to identify patients at high risk for severe complications, who can most likely benefit from adjuvant treatment after thrombectomy to improve patient functional independence and survival rate.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30
• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Symptoms and signs compatible with ischemia in the anterior circulation
2. Internal carotid artery occlusion or middle cerebral artery M1 and M2 segment occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)
3. Premorbid mRS ≤1;
4. National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
5. Onset to puncture time ≤24h;
6. Treated with thrombectomy resulting in mTICI score ≥2b at end of the procedure.

Exclusion Criteria

1. Intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy;
2. Perioperative complications, including dissection and arterial perforation;
3. Anticipated life expectancy <3 months;
4. Critical baseline clinical, laboratory and imaging data are missing;
5. Lack of follow-up results within 72 hours and 90 days after thrombectomy;
6. Pregnant or lactating women;
7. Severe systemic diseases (e.g. advanced cancer), potentially interfering with prognosis;
8. Allergy to contrast media and nitinol;
9. Concurrent participation in a study that would interfere with the establishment of predictive models;
10. Unable to complete the assessment due to mental disorders cognitive or emotional disorders before onset.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of severe complications	Within 72 hours after thrombectomy	Severe complications include symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE). SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration.; MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri.

Secondary Outcome Measures

Name	Time	Method
Rate of symptomatic intracranial hemorrhage	Within 72 hours after thrombectomy	SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration.
Rate of modified Rankin Scale (mRS) score of 0-2	90 days (±7 days) after thrombectomy	The mRS score range from 0 (no disability) to 6 (death)
Rate of malignant cerebral edema	Within 72 hours after thrombectomy	MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri.
Rate of mRS score of 5-6	90 days (±7 days) after thrombectomy	The mRS score range from 0 (no disability) to 6 (death)
Change of NIHSS score	24-72 hours after thrombectomy versus admission	The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
All-cause mortality	90 days (±7 days) after thrombectomy	Death defined as a mRS score of 6
Rate of mRS score of 3-6	90 days (±7 days) after thrombectomy	The mRS score range from 0 (no disability) to 6 (death)

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China