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Establishment and Validation of a Predictive Model for Hemorrhage

NCT04745052 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2021-02-09

No results posted yet for this study

Summary

Background: Patients with acute ischemic stroke (AIS) are at risk of hemorrhagic transformation (HT) after intravenous thrombolysis. Although there is a risk assessment model for hemorrhagic transformation after thrombolysis, there is no evidence of clinical application in the population of Guangdong Province. .

Purpose: To verify the clinical application effect of the existing risk assessment model for hemorrhage transformation after thrombolysis in the local population; to improve the existing prediction model and verify the predictive value of HT after intravenous thrombolysis.

Methods: (1) Continuously collect AIS patients who received intravenous thrombolysis in our hospital from January 2014 to December 2020 to verify the clinical application effects of three existing models (HAT, SIT-sICH, THRIVE) on bleeding transformation. Collect baseline and bleeding transformation information within 7 days after thrombolysis, and use ROC curve, calibration curve, sensitivity and specificity to evaluate the prediction effect. A logistic regression model was used to construct an improved HT prediction model based on the AIC principle; (2) Continuous collection of AIS patients who received intravenous thrombolysis in two local hospitals from January 2021 to December 2022 for internal and external verification.

Expected results: (1) Evaluate the clinical application value of the existing prediction model in local AIS patients with intravenous thrombolysis; (2) Develop a modified risk assessment model suitable for hemorrhage transformation after intravenous thrombolysis in AIS patients in Guangdong area, and evaluate the risk early Provide guarantee for clinical diagnosis and treatment.

Conditions

  • Stroke, Acute

Interventions

OTHER

Clinical observation index

The first is to verify the application effect of intravenous thrombolytic hemorrhage prediction models (HAT, SIT-sICH, THRIVE) in the population of acute ischemic stroke in Guangdong Province, and verify the clinical application effects of existing prediction models. Secondly, analyze the predictive value of clinical indicators, optimize HAT, SIT-sICH, and THRIVE scores, construct an improved HT prediction model, and optimize and improve the existing prediction model. The third is to apply the improved HT prediction model to the clinic, collect clinical data prospectively, evaluate the prediction effect of the model, and evaluate the clinical application effect of the improved prediction model.

Sponsors & Collaborators

  • Shenzhen Second People's Hospital

    lead OTHER

Principal Investigators

  • Xie Xiaohua, master · Director of Nursing

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-12-31
Completion
2023-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745052 on ClinicalTrials.gov