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Clinical Trials/NCT04554368
NCT04554368
Completed
Not Applicable

A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage After Stroke Thrombectomy: Derivation, Validation and Comparison With Other Scores

Shanghai Jiao Tong University Affiliated Sixth People's Hospital1 site in 1 country300 target enrollmentJune 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracerebral Hemorrhage
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Enrollment
300
Locations
1
Primary Endpoint
Henan predicting the risk of intracerebral hemorrhage score
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2015
End Date
March 30, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yueqi Zhu

Clinical Professor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Eligibility Criteria

Inclusion Criteria

  • age ≥18 years,
  • occlusion of internal carotid artery and/or middle cerebral artery (MCA) M1 or M2 segments confirmed by CTA or MRA or DSA,
  • baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points,
  • MT was performed within 16 hours from stroke onset,
  • 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

  • bilateral infarcts,
  • history of hemorrhagic stroke,
  • post-procedure ICH (including SAH) due to iatrogenic complications,
  • missing clinical and demographic data,
  • 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.

Outcomes

Primary Outcomes

Henan predicting the risk of intracerebral hemorrhage score

Time Frame: 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.

Study Sites (1)

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