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Establishment and Validation of a Predictive Model for Hemorrhage

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ClinicalTrials.gov Identifier: NCT04745052
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Shenzhen Second People's Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Stroke, Acute Other: Clinical observation index

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 Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Establishment and Validation of a Predictive Model for Hemorrhage After Intravenous Thrombolysis in Acute Ischemic Stroke
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ischemic stroke in Shenzhen Second People's Hospital
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745052


Contacts
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Contact: Xie Xiaohua, master +86 13560779836 13560779836@163.com
Contact: Yang Jie, master 15805605793 1029784141@qq.com

Locations
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China, Guangdong
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518035
Contact: Xie Xiaohua, master    13560779836    13560779836@163.com   
China, Shenzhen
China
Guandong, Shenzhen, China, 518035
Contact: Xie Xiaohua, master    13560779836    13560779836@163.com   
Sponsors and Collaborators
Shenzhen Second People's Hospital
Investigators
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Principal Investigator: Xie Xiaohua, master Director of Nursing
More Information
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Responsible Party: Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT04745052    
Other Study ID Numbers: 20203357004
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shenzhen Second People's Hospital:
Hemorrhagic transformation
Thrombolysis
Additional relevant MeSH terms:
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Stroke
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes