Safety and efficacy of remote ischemic conditioning for spontaneous intracerebral hemorrhage (SERIC-ICH): A multicenter, randomized, parallel-controlled clinical trial study design and protocol.
Eur Stroke J
; 9(1): 259-264, 2024 Mar.
Article
em En
| MEDLINE
| ID: mdl-37752799
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 (11) 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Hemorragia Cerebral
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Aged
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Eur Stroke J
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
China