A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

NCT04554368 | Completed

• 1 other identifier: Henan-PRIH score
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage; Thrombectomy; Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IA-CEFDCT group

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

Procedure: intra-arterial contrast enhanced Flat Detector CT

Interventions

intra-arterial contrast enhanced Flat Detector CT PROCEDURE

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.

IA-CEFDCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with acute anterior circulation stroke

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, 200023, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 18, 2020
• Study Start: June 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: March 30, 2020
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)