Establishment and Validation of a Predictive Model for Hemorrhage
1 other identifier
observational
240
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 9, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFebruary 9, 2021
February 1, 2021
1.8 years
February 4, 2021
February 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Build HT prediction model
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
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patients with ischemic stroke in Shenzhen Second People's Hospital
You may qualify if:
- Age ≥ 18 years old;
- Onset time \<4.5 hours;
- 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;
- AIS patients receiving intravenous thrombolysis.
You may not qualify if:
- The main clinical data is incomplete;
- Patients treated by intraarterial thrombolysis or interventional thrombectomy;
- Patients with transient ischemic attack;
- Those who refuse to participate in this research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
China
Guandong, Shenzhen, 518035, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xie Xiaohua, master
Director of Nursing
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 9, 2021
Study Start
March 1, 2021
Primary Completion
December 31, 2022
Study Completion
July 1, 2023
Last Updated
February 9, 2021
Record last verified: 2021-02