A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Intracerebral Hemorrhage; Thrombectomy
• Intervention / Treatment: Procedure: intra-arterial contrast enhanced Flat Detector CT

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200023
    • Shanghai 6th People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with acute anterior circulation stroke

Description

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 9 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 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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

IA-CEFDCT group; 95 patients who underwent IA-CEFDCT and MT for acute anterior stroke.

Procedure: intra-arterial contrast enhanced Flat Detector CT; After femoral artery puncture, FDCT scan (if necessary) and IA-CEFDCT scan were performed on a single flat-detector angiography system (Allura Xper FD20, Philips Medical systems, Best, the Netherlands), respectively. FDCT was acquired with the following acquisition parameters: 20s rotation, 220° rotation, 617 single frames at a frame rate of 30/s, 48cm detector field of view, 1024 acquisition matrix. Images were reconstructed using a soft-tissue kernel with an isotropic voxel size of 0.9 × 0.9 × 0.9 mm on a dedicated workstation for FPCT data (XperCT Dual 3.2.0). For image analysis, these isotropic FDCT data were viewed in the axial plane with 5 mm slice thickness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Henan predicting the risk of intracerebral hemorrhage score	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.	5 days

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Collaborators: The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: September 13, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: Henan-PRIH score

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be made avaliable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No