Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

Journal：thrombosis journal

Publication type: Research

IF(IF): 3.1

PMID: 38419108 Link To Pubmed Full text Download

China bears the biggest stroke burden in the world. Stroke incidence in China, particularly the incidence of intracerebral hemorrhage (25%), was greater than in high-income countries (9-13%) and similar to other low- to middle-income countries (14-27%). Spontaneous intracerebral hemorrhage (ICH) is a severe subtype of stroke that causes permanent morbidity, neurocognitive disability, long-term functional impairment, and mortality in the majority of patients. A high prevalence of paresis may make patients with ICH susceptible to venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE). Studies showed that rates of VTE were as much as 4 times higher in ICH than in ischemic stroke patients. Rates of symptomatic VTE after ICH range from 1% to 10%, with rates between 20% and 80% for asymptomatic VTE, identified by duplex ultrasound, fibrinogen scanning, or MRI. Without VTE prophylaxis, up to 75% of patients with hemiplegia after stroke develop DVT. Guidelines from the American Heart Association/American Stroke Association suggest that patients with ICH should have intermittent pneumatic compression(IPC) for prevention of VTE beginning the day of hospital admission (Class I; Level of Evidence A), while low-dose subcutaneous unfractionated heparin (UH) or low molecular weight heparin (LMWH) may be considered after documentation of cessation of bleeding for prevention of VTE in patients with lack of mobility after 1 to 4 days from onset (Class IIb; Level of Evidence B). The optimal timing and dosage of prophylactic and therapeutic anticoagulation for VTE in the ICH population remain incompletely defined, specifically regarding how to balance the neurological risk of hematoma expansion after anticoagulation against the clinical sequelae of an untreated VTE. Because the guidelines are not accepted broadly and the evidence is weak, the compliance of VTE prevention in the real world may be not sufficient. In an observational cohort study, among 74 283 patients with ICH from 1358 hospitals,5929 (7.9%) received early chemoprophylaxis, 66444(89.4%)received early mechanical/non- chemoprophylaxis,1910(2.6%)had no prophylaxis. An analysis of the China National Stroke Registry indicated that among 4643 acute ischemic stroke patients eligible for DVT prophylaxis, the overall adherence rate of DVT prophylaxis was 59.6%. But little is known about the clinical practice of DVT prophylaxis in patients with ICH in China. Therefore, this article analyzed results from the Chinese Stroke Center Alliance with the following objectives: (1)determine the rate of DVT prophylaxis in ICH patients;(2)analyze the type of DVT prophylaxis;(3)identify predictors of DVT prophylaxis in ICH patients;(4)assess the association between DVT prophylaxis and outcomes in ICH patients.

This study was conducted from the Chinese Stroke Center Alliance (CSCA).The CSCA is a national, hospital-based, voluntary, multifaceted intervention and continuous quality improvement initiative. It provides a unique platform to develop stroke centers and improve stroke care quality and clinical outcomes. The CSCA programme was initiated by the CSA in June 2015. Data submission for the CSCA was initiated on August 2015. The data coordinating center of the CSCA resides at the China National Clinical Research Center for Neurological Diseases, the Beijing Tiantan Hospital. The study was approved by the Central Institutional Review Board at the Beijing Tiantan Hospital. The written consent was obtained from participating patients. According to the World Health Organization criteria within 14days of the index event, the current analysis included patients in CSCA who had been diagnosed with acute intracerebral hemorrhage from August 2015 to July 2019. DVT prophylaxis and definition of VTE Non-ambulatory patients with acute intracerebral hemorrhage patients were eligible for DVT prophylaxis. Patients were excluded if they met any of the following criteria: contraindications for intermittent pneumatic compression or anticoagulants, patient/family refusal, or terminal illness/comfort care only, and death before the end of hospital day two. Deep venous thrombosis prophylaxis included pneumatic compression devices, subcutaneous UH, LMWH, or other anticoagulation (e.g. with heparin or warfarin). The clinical diagnosis of VTE was made according to the medical documentation. Statistical analysis The adherence rate of DVT prophylaxis was defined as that the proportion of eligible patients who received DVT prophylaxis divided by the total number of patients eligible for the intervention, excluding those who had contraindications or other documented reasons to treatment. Results were also summated at the hospital level. Numbers (percentages) were calculated for categorical variables and median values with interquartile ranges (IQRs) were used to describe continuous variables. Baseline patient- and hospital level characteristics were compared between patients who received DVT prophylaxis and those who did not by using Pearson’s chi-square tests for categorical variables. Student’s t-test or Mann–Whitney’s U test were used to compare continuous variables. Univariate associations between patient and hospital level baseline characteristics and DVT prophylaxis were evaluated by using single-predictors logistic regression models. Then, all these variables were entered into a multivariable logistic regression model that used the standard generalised estimating equation method. Levels of a multilevel variable were compared individually to the reference group. We calculated the rate of VTE among total eligible patients and those with or without DVT prophylaxis separately. A simple test of association was performed by using a Pearson’s chi-square test. All tests are two-tailed with P<0.05 to be considered the level of statistical significance. All analyses were performed by using SAS Version 9.3 software .