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OpenTrials
Completed

NCT Number: NCT06498778

Etiology and Prognosis of sICH Based on Hemorrhage Location

The investigators retrospectively collected participants with spontaneous cerebral hemorrhage(sICH) from January 2015 to December 2019 for training and internal validation. Clinical and imaging data were collected. Modified Rankin Scale (mRS) scores were determined good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6". The location features of sICH were extracted by symptom mapping. Noncontrast computed tomography images of patients and hematoma masks were registered with standard human brain templates to identify specific affected brain regions. Then a probability map of hemorrhage for different causes and prognosis is generated. PyRadiomics was used to extract the radiomic features, integrate radiomic and clinical features into multiple logistic regression models, and develop and validate optimal etiological and prognostic models. Further tests were performed in an independent cohort. The area under the working characteristic curve (AUC), sensibility, specificity were used to evaluate the reliability of the model.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinling Hospital

Nanjing, Jiangsu, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The confirmation of intracranial hemorrhage was achieved through NCCT.

Exclusion criteria

  • They presented with secondary hemorrhage resulting from head trauma, hemorrhagic transformation of ischemic infarction, brain tumors, or exhibited abnormalities in blood coagulation, liver, kidney function, or were subject to drug-induced cerebral hemorrhage
  • Only postoperative CT images were available
  • Lost follow-up records
  • CT image artifacts

Treatment and study plan

Primary outcomes

  1. Modified Rankin Scale (mRS) scores

    Time frame: follow-ups at twelve months post sICH event

    Good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6"

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

Prediction of Etiology and Prognosis Based on Hematoma Location of Spontaneous Intracerebral Hemorrhage

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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