An observational study in Stroke, Cerebrovascular Diseases and Cerebral Infarction, sponsored by Ministry of Science and Technology of the People´s Republic of China. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by Ministry of Science and Technology of the People´s Republic of China · Observational
In this protocol, the investigators present methods and preliminary results from the PLATFORM-CVD Study, an EHR-based multicenter cohort. This study will focus on assessing the distribution of major cerebrovascular diseases, determining the risk factors associated with disease incidence and worse in-hospital outcomes, as well as describing the quality of care. Data from this cohort will be used to develop suitable prediction models for cerebrovascular diseases using real-world data and to understand how outcomes for cerebrovascular diseases would change with quality improvement interventions.
Adherence to healthcare quality measures is needed to reduce the burden of cerebrovascular disease and improve clinical outcomes. Electronic health records (EHRs) can facilitate the standardization of care provision and the improvement of disease prediction and prevention. Although the EHRs in clinical settings are increasingly prevalent in China, they are rarely used for healthcare research. the investigators aimed to conduct an EHR-based registry study to improve the healthcare and outcomes for cerebrovascular diseases.
Twenty-four hospitals were enrolled in the PLATFORM-CVD Study in January 2018. Data collection began on February 1st, 2019. Historical data from January 2017 are abstracted first and prospective data are continuously reported until May 20th, 2020. Data were abstracted from the medical records, including hospital information system, laboratory information management system, and picture archiving and communication systems by an extract-transform-load tool. The EHR system included diagnostic information for cerebral infarctions (I63), nontraumatic intracerebral hemorrhages (I61), nontraumatic subarachnoid hemorrhages (I60), transient cerebral ischemic attacks and related syndromes (G45), intracranial and intraspinal phlebitis and thrombophlebitis (G08), vascular dementia (F01), and other aneurysms (I72). The quality of stroke care was assessed by 21 evidence-based performance measures. In-hospital outcomes were calculated including mortality, length of stay, and costs.
The PLATFORM-CVD Study leverages EHRs to better understand incident cerebrovascular diseases in China. Data from this cohort will serve as a unique platform for quality assessment and improvement for acute treatment and secondary prevention of cerebrovascular diseases, as well as in-hospital outcome risk predictions and health economic evaluations.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's planned enrollment of 300,000 is above the median of 117 across 226 observational studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →Ministry of Science and Technology of the People´s Republic of China is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
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Twenty-five hospitals were enrolled in the PLATFORM-CVD Study between January 1st, 2017 and May 20th, 2020. Hospitals were included if they: 1) had neurological wards; 2) were secondary or tertiary hospitals; 3) could admit at least 20 cerebrovascular disease patients every month.
Exclusion Criteria:
In-hospital mortality
Patients who died during hospitalization due to cerebrovascular diseases
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Length of stay at hospital
The total days for a patients with cerebrovascular diseases at hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Costs
The total costs for a patients with cerebrovascular diseases at hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antiplatelet medication use
Rate of antiplatelet therapy during hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of dual antiplatelet medication use for non-disabling IS and TIA events
Rate of aspirin and clopidogrel therapy for ischemic cerebrovascular diseases (IS or TIA) during hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours
Patients at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression, warfarin sodium, and novel oral anticoagulant
Time frame: 48 hours within hospitalization
Cerebrovascular assessment ≤ seven days
Cerebrovascular assessment (TCD, IVUS, brain CT or MR scan) within seven days of hospitalization
Time frame: 7 days within hospitalization
Statin therapy for LDL ≥100 mg/dL during hospitalization
Lipid lowering agent prescribed during hospitalization if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication use for atrial fibrillation during hospitalization
Anticoagulation prescribed during hospitalization in patients with documented atrial fibrillation
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antithrombotic medication prescribtion at discharge
Antithrombotic therapy prescribed at discharge, including antiplatelet or anticoagulant therapy
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antihypertensive medication prescribtion for patients with hypertension at discharge
Antihypertension medication prescribed at discharge for patients with history of hypertension disease or hypertension disease documented during the hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of statin prescribtion for low-density lipoprotein≥100 mg/dL at discharge
Lipid lowering agent prescribed at discharge if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycaemia medication prescribtion for diabetes mellitus at discharge
Hypoglycemic medication prescribed at discharge for patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication prescribtion for atrial fibrillation at discharge
Anticoagulation prescribed at discharge in patients with documented atrial fibrillation
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombolytic therapy
Intravenous r-tPA in IS patients
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombectomy therapy
Thrombectomy therapy for IS patients
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for ICH
Patients with ICH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression.
Time frame: 48 hours within hospitalization
Rate of antihypertensive medicine use for ICH patients with hypertension at discharge
Antihypertension medication prescribed at discharge for ICH patients with history of hypertension disease or hypertension disease documented during the hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycemia medication use for ICH patients with diabetes mellitus at discharge
Hypoglycemic medication prescribed at discharge for ICH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for ICH patients
Neurosurgery of ICH include removal of hematoma by craniotomy, aspiration of hematoma by drilling, decompressive craniectomy, ventriculocentesis and drainage, other removal of intracranial hematoma
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for SAH
Patients with SAH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression
Time frame: 48 hours within hospitalization
Rate of antihypertensive medicine use for SAH patients with hypertension at discharge
Antihypertension medication prescribed at discharge for SAN patients with history of hypertension disease or hypertension disease documented during the hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycemia medication use for SAH patients with diabetes mellitus at discharge
Hypoglycemic medication prescribed at discharge for SAH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for SAH patients
Neurosurgery of SAH include aneurysm clipping, endovascular embolization of aneurysm, extraventricular shunt
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Plan to share: Yes — We will share the data dictionary of the study. The data could be applied by the PI's email. Applicant should make an SAP first. The PI will check the SAP and appoint a statistician for the analysis.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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Ministry of Science and Technology of the People´s Republic of China