Dataset Information

Safety and efficacy of remote ischemic conditioning for spontaneous intracerebral hemorrhage (SERIC-ICH): A multicenter, randomized, parallel-controlled clinical trial study design and protocol.

ABSTRACT:

Background

Previous studies have revealed that remote ischemic conditioning (RIC) may have a neuroprotective function. However, the potential benefit of RIC for patients with ICH remain unclear.

Objective

The primary aim of this study is to assess the safety and efficacy of RIC for patients with ICH.

Methods

The Safety and Efficacy of RIC for Spontaneous ICH (SERIC-ICH) is an ongoing prospective, randomized, multicenter, parallel-controlled, and blinded-endpoint clinical trial. The study will enroll an estimated 2000 patients aged ⩾18 years within 24 h after ICH onset, with National Institutes of Health Stroke Scale ⩾6 and Glasgow Coma Scale ⩾8 upon presentation. The patients will be randomly assigned to the RIC or control groups (1:1) and will be treated with cuffs inflated to a pressure of 200 or 60 mmHg, respectively, twice daily for 7 days. Each RIC treatment will consist of four cycles of arm ischemia for 5 min, followed by reperfusion for another 5 min, for a total procedure time of 35 min. The primary efficacy outcome measure is the proportion of patients with good functional outcomes (modified Rankin scale 0-2) at 180 days. The safety outcome measures will include all adverse events and severe adverse events occurring in the course of the study.

Discussion

RIC is an inexpensive intervention and might be a strategy to improve outcomes in patients with ICH. The SERIC-ICH trial will investigate whether RIC treatment can be applied as an adjuvant treatment in the acute phase of ICH and identify safety issues.

SUBMITTER: Guo ZN

PROVIDER: S-EPMC10916805 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety and efficacy of remote ischemic conditioning for spontaneous intracerebral hemorrhage (SERIC-ICH): A multicenter, randomized, parallel-controlled clinical trial study design and protocol.

Guo Zhen-Ni ZN Qu Yang Y Abuduxukuer Reziya R Zhang Peng P Wang Lijuan L Liu Ying Y Teng Rui-Hong RH Gao Jian-Hua JH Jin Feng F Wang Hai-Feng HF Cao Yu Y Xue Yong-Quan YQ Zhao Jun-Feng JF Selim Magdy H MH Nguyen Thanh N TN Yang Yi Y

European stroke journal 20230926 1

<h4>Background</h4>Previous studies have revealed that remote ischemic conditioning (RIC) may have a neuroprotective function. However, the potential benefit of RIC for patients with ICH remain unclear.<h4>Objective</h4>The primary aim of this study is to assess the safety and efficacy of RIC for patients with ICH.<h4>Methods</h4>The Safety and Efficacy of RIC for Spontaneous ICH (SERIC-ICH) is an ongoing prospective, randomized, multicenter, parallel-controlled, and blinded-endpoint clinical tr ...[more]

PMID: 37752799

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Project description:Spontaneous Intracerebral hemorrhage (ICH) is a devastating injury that accounts for 10-15% of all strokes. The rupture of cerebral blood vessels damaged by hypertension or cerebral amyloid angiopathy creates a space-occupying hematoma that contributes toward neurological deterioration and high patient morbidity and mortality. Numerous protocols have explored a role for surgical decompression of ICH via craniotomy, stereotactic guided endoscopy, and minimally invasive catheter/tube evacuation. Studies including, but not limited to, STICH, STICH-II, MISTIE, MISTIE-II, MISTIE-III, ENRICH, and ICES have all shown that, in certain limited patient populations, evacuation can be done safely and mortality can be decreased, but functional outcomes remain statistically no different compared to medical management alone. Only 10-15% of patients with ICH are surgical candidates based on clot location, medical comorbidities, and limitations regarding early surgical intervention. To date, no clearly effective treatment options are available to improve ICH outcomes, leaving medical and supportive management as the standard of care. We recently identified that remote ischemic conditioning (RIC), the non-invasive, repetitive inflation-deflation of a blood pressure cuff on a limb, non-invasively enhanced hematoma resolution and improved neurological outcomes via anti-inflammatory macrophage polarization in pre-clinical ICH models. Herein, we propose a pilot, placebo-controlled, open-label, randomized trial to test the hypothesis that RIC accelerates hematoma resorption and improves outcomes in ICH patients. Twenty ICH patients will be randomized to receive either mock conditioning or unilateral arm RIC (4 cycles × 5 min inflation/5 min deflation per cycle) beginning within 48 h of stroke onset and continuing twice daily for one week. All patients will receive standard medical care according to latest guidelines. The primary outcome will be the safety evaluation of unilateral RIC in ICH patients. Secondary outcomes will include hematoma volume/clot resorption rate and functional outcomes, as assessed by the modified Rankin Scale (mRS) at 1- and 3-months post-ICH. Additionally, blood will be collected for exploratory genomic analysis. This study will establish the feasibility and safety of RIC in acute ICH patients, providing a foundation for a larger, multi-center clinical trial.

Project description:PurposeWe develop a new risk score to predict patients with stroke-associated pneumonia (SAP) who have an acute intracranial hemorrhage (ICH).MethodWe applied logistic regression to develop a new risk score called ICH-LR2S2. It was derived from examining a dataset of 70,540 ICH patients between 2015 and 2018 from the Chinese Stroke Center Alliance (CSCA). During the training of ICH-LR2S2, patients were randomly divided into two groups - 80% for the training set and 20% for model validation. A prospective test set was developed using 12,523 patients recruited in 2019. To further verify its effectiveness, we tested ICH-LR2S2 on an external dataset of 24,860 patients from the China National Stroke Registration Management System II (CNSR II). The performance of ICH-LR2S2 was measured by the area under the receiver operating characteristic curve (AUROC).ResultsThe incidence of SAP in the dataset was 25.52%. A 24-point ICH-LR2S2 was developed from independent predictors, including age, modified Rankin Scale, fasting blood glucose, National Institutes of Health Stroke Scale admission score, Glasgow Coma Scale score, C-reactive protein, dysphagia, Chronic Obstructive Pulmonary Disease, and current smoking. The results showed that ICH-LR2S2 achieved an AUC = 0.749 [95% CI 0.739-0.759], which outperforms the best baseline ICH-APS (AUC = 0.704) [95% CI 0.694-0.714]. Compared with the previous ICH risk scores, ICH-LR2S2 incorporates fasting blood glucose and C-reactive protein, improving its discriminative ability. Machine learning methods such as XGboost (AUC = 0.772) [95% CI 0.762-0.782] can further improve our prediction performance. It also performed well when further validated by the external independent cohort of patients (n = 24,860), ICH-LR2S2 AUC = 0.784 [95% CI 0.774-0.794].ConclusionICH-LR2S2 accurately distinguishes SAP patients based on easily available clinical features. It can help identify high-risk patients in the early stages of diseases.

Project description:BackgroundMisdiagnosis of hemorrhage secondary to cerebral venous sinus thrombosis (CVST-ICH) as arterial-origin spontaneous intracerebral hemorrhage (sICH) can lead to inappropriate treatment and the potential for severe adverse outcomes. The current practice for identifying CVST-ICH involves venography, which, despite being increasingly utilized in many centers, is not typically used as the initial imaging modality for ICH patients. The study aimed to develop an explainable deep learning model to quickly identify ICH caused by CVST based on non-contrast computed tomography (NCCT).MethodsThe study population included patients diagnosed with CVST-ICH and other spontaneous ICH from January 2016 to March 2023 at the Second Affiliated Hospital of Zhejiang University, Taizhou First People's Hospital, Taizhou Hospital, Quzhou Second People's Hospital, and Longyan First People's Hospital. A transfer learning-based 3D U-Net with segmentation and classification was proposed and developed only on admission plain CT. Model performance was assessed using the area under the curve (AUC), sensitivity, and specificity metrics. For further evaluation, the average diagnostic performance of nine doctors on plain CT was compared with model assistance. Interpretability methods, including Grad-CAM++, SHAP, IG, and occlusion, were employed to understand the model's attention.FindingsAn internal dataset was constructed using propensity score matching based on age, initially including 102 CVST-ICH patients (median age: 44 [29, 61] years) and 683 sICH patients (median age: 65 [52, 73] years). After matching, 102 CVST-ICH patients and 306 sICH patients (median age: 50 [40, 62] years) were selected. An external dataset consisted of 38 CVST-ICH and 119 sICH patients from four other hospitals. Validation showed AUC 0·94, sensitivity 0·96, and specificity 0·8 for the internal testing subset; AUC 0·85, sensitivity 0·87, and specificity 0·82 for the external dataset, respectively. The discrimination performance of nine doctors interpreting CT images significantly improved with the assistance of the proposed model (accuracy 0·79 vs 0·71, sensitivity 0·88 vs 0·81, specificity 0·75 vs 0·68, p < 0·05). Interpretability methods highlighted the attention of model to the features of hemorrhage edge appearance.InterpretationThe present model demonstrated high-performing and robust results on discrimination between CVST-ICH and spontaneous ICH, and aided doctors' diagnosis in clinical practice as well. Prospective validation with larger-sample size is required.FundingThe work was funded by the National Key R&D Program of China (2023YFE0118900), National Natural Science Foundation of China (No.81971155 and No.81471168), the Science and Technology Department of Zhejiang Province (LGJ22H180004), Medical and Health Science and Technology Project of Zhejiang Province (No.2022KY174), the 'Pioneer' R&D Program of Zhejiang (No. 2024C03006 and No. 2023C03026) and the MOE Frontier Science Center for Brain Science & Brain-Machine Integration, Zhejiang University.

Project description:ImportanceHyperintense foci on diffusion-weighted imaging (DWI) that are spatially remote from the acute hematoma occur in 20% of people with acute spontaneous intracerebral hemorrhage (ICH). Tranexamic acid, a hemostatic agent that is under investigation for treating acute ICH, might increase DWI hyperintense lesions (DWIHLs).ObjectiveTo establish whether tranexamic acid compared with placebo increased the prevalence or number of remote cerebral DWIHLs within 2 weeks of ICH onset.Design, setting, and participantsThis prospective nested magnetic resonance imaging (MRI) substudy of a randomized clinical trial (RCT) recruited participants from the multicenter, double-blind, placebo-controlled, phase 3 RCT (Tranexamic Acid for Hyperacute Primary Intracerebral Hemorrhage [TICH-2]) from July 1, 2015, to September 30, 2017, and conducted follow-up to 90 days after participants were randomized to either the tranexamic acid or placebo group. Participants had acute spontaneous ICH and included TICH-2 participants who provided consent to undergo additional MRI scans for the MRI substudy and those who had clinical MRI data that were compatible with the brain MRI protocol of the substudy. Data analyses were performed on an intention-to-treat basis on January 20, 2020.InterventionsThe tranexamic acid group received 1 g in 100-mL intravenous bolus loading dose, followed by 1 g in 250-mL infusion within 8 hours of ICH onset. The placebo group received 0.9% saline within 8 hours of ICH onset. Brain MRI scans, including DWI, were performed within 2 weeks.Main outcomes and measuresPrevalence and number of remote DWIHLs were compared between the treatment groups using binary logistic regression adjusted for baseline covariates.ResultsA total of 219 participants (mean [SD] age, 65.1 [13.8] years; 126 men [57.5%]) who had brain MRI data were included. Of these participants, 96 (43.8%) were randomized to receive tranexamic acid and 123 (56.2%) were randomized to receive placebo. No baseline differences in demographic characteristics and clinical or imaging features were found between the groups. There was no increase for the tranexamic acid group compared with the placebo group in DWIHL prevalence (20 of 96 [20.8%] vs 28 of 123 [22.8%]; odds ratio [OR], 0.71; 95% CI, 0.33-1.53; P = .39) or mean (SD) number of DWIHLs (1.75 [1.45] vs 1.81 [1.71]; mean difference [MD], -0.08; 95% CI, -0.36 to 0.20; P = .59). In an exploratory analysis, participants who were randomized within 3 hours of ICH onset or those with chronic infarcts appeared less likely to have DWIHLs if they received tranexamic acid. Participants with probable cerebral amyloid angiopathy appeared more likely to have DWIHLs if they received tranexamic acid.Conclusions and relevanceThis substudy of an RCT found no evidence of increased prevalence or number of remote DWIHLs after tranexamic acid treatment in acute ICH. These findings provide reassurance for ongoing and future trials that tranexamic acid for acute ICH is unlikely to induce cerebral ischemic events.Trial registrationisrctn.org Identifier: ISRCTN93732214.

Dataset Information

Safety and efficacy of remote ischemic conditioning for spontaneous intracerebral hemorrhage (SERIC-ICH): A multicenter, randomized, parallel-controlled clinical trial study design and protocol.

Background

Objective

Methods

Discussion

Publications

Safety and efficacy of remote ischemic conditioning for spontaneous intracerebral hemorrhage (SERIC-ICH): A multicenter, randomized, parallel-controlled clinical trial study design and protocol.

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