Establishment and Validation of a Predictive Model for Hemorrhage

February 4, 2021 updated by: Shenzhen Second People's Hospital

Establishment and Validation of a Predictive Model for Hemorrhage After Intravenous Thrombolysis in Acute Ischemic Stroke

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study has two main parts. The first part is to verify and optimize the clinical application effect of the existing prediction model. The clinical data of the acute ischemic stroke intravenous thrombolytic population is collected retrospectively, mainly including baseline indicators and 7 days after thrombolysis Internal bleeding, based on the existing prediction models (HAT, SIT-sICH, THRIVE), calculate the prediction probability, and compare it with the actual bleeding situation, evaluate the clinical application effect of the prediction model, use ROC curve, calibration curve, sensitivity and Evaluation of indicators such as specificity. Using retrospective data, using multivariate logistic regression to analyze the predictive value of baseline clinical indicators, screening risk factors, and optimizing the HAT, SIT-sICH, and THRIVE prediction models. The logistic regression model is used to construct an improved HT prediction model based on the AIC principle; the method of model comparison is used to combine the clinical significance of the indicators to complete the construction of the prediction model. The second part is to evaluate the clinical application effect of the improved prediction model, and prospectively collect clinical data of AIS patients undergoing intravenous thrombolysis in Shenzhen Second People's Hospital, Shenzhen Longhua District People's Hospital, including general demographic data and laboratory tests Baseline indicators such as imaging examinations, bleeding within 7 days after thrombolysis, etc., were used to verify the improved HT prediction model using ROC curve, calibration curve, sensitivity and specificity, and external verification was performed to evaluate the prediction effect of the model.

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518035
        • Shenzhen Second People's Hospital
        • Contact:
    • Shenzhen
      • Guandong, Shenzhen, China, 518035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 ischemic stroke in Shenzhen Second People's Hospital

Description

Inclusion Criteria:

  1. Age ≥ 18 years old;
  2. Onset time <4.5 hours;
  3. Meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, and have been examined by plain CT/MRI of the head, and hemorrhagic stroke is excluded by head CT;
  4. AIS patients receiving intravenous thrombolysis.

Exclusion Criteria:

  1. The main clinical data is incomplete;
  2. Patients treated by intraarterial thrombolysis or interventional thrombectomy;
  3. Patients with transient ischemic attack;
  4. Those who refuse to participate in this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute ischemic stroke
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Build HT prediction model
Time Frame: March 1, 2021 to March 1, 2022
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. Use logistic regression model to build an improved HT prediction model based on AIC principles
March 1, 2021 to March 1, 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Second People's Hospital

Investigators

  • Principal Investigator: Xie Xiaohua, master, Director of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20203357004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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