A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

Completed

• Conditions: Thrombectomy; Stroke; Intracerebral Hemorrhage
• Interventions: Procedure: intra-arterial contrast enhanced Flat Detector CT

• Registration Number: NCT04554368
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Brief Summary

This study sought to develop and validate a new risk stratification score (Henan predicting the risk of intracerebral hemorrhage score, Henan-PRIHS) based on intra-arterial contrast enhanced Flat Detector CT (IA-CEFDCT) to predict symptomatic intra-cerebral hemorrhage (sICH) after stroke thrombectomy.

Detailed Description

The Henan-PRIHS was developed from 95 patients who underwent IA-CEFDCT and MT for acute anterior stroke. Patients were classified as having one of three grades according to the presence of contrast filling within the occluded vascular territory. Grade 0 was normal or less contrast filling in affected hemisphere, grade 1 and 2 were small and medium-large area without contrast filling, respectively. The Youden index was used to determine the optimum no contrast filling area cutoff for defining grade 1 and 2. The score was subsequently validated in a different population of 208 patients and compared with three established scores.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-30
• Study First Submitted: 2020-09-13
• Study First Submitted QC: 2020-09-13
• Study First Posted: 2020-09-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. age ≥18 years,
2. occlusion of internal carotid artery and/or middle cerebral artery (MCA) M1 or M2 segments confirmed by CTA or MRA or DSA,
3. baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points,
4. MT was performed within 16 hours from stroke onset,
5. baseline CT scan and IA-CEFDCT scan must be performed; 24 hours post-treatment CT scan was done and when the patient's neurological state had deteriorated.

Exclusion Criteria

1. bilateral infarcts,
2. history of hemorrhagic stroke,
3. post-procedure ICH (including SAH) due to iatrogenic complications,
4. missing clinical and demographic data,
5. poor-quality IA-CEFDCT scans (i.e., motion artifact) that limited accurate identification of the region of interest. Bridge treatment (combined intravenous thrombolysis with MT) was not excluded from this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IA-CEFDCT group	intra-arterial contrast enhanced Flat Detector CT	95 patients who underwent IA-CEFDCT and MT for acute anterior stroke.

Primary Outcome Measures

Name	Time	Method
Henan predicting the risk of intracerebral hemorrhage score	5 days	Grade 0 was normal or less contrast filling in affected hemisphere, grade 1 and 2 were small and medium-large area without contrast filling, respectively.

Trial Locations

Locations (1)

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, China