A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554368
• Other study ID #: Henan-PRIH score
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: March 30, 2020

Study information

• Verified date: November 2023
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Stroke
• Thrombectomy

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai 6th People's Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital	The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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