Clinical re-evaluation of removing blood stasis therapy in treating acute intracerebral hemorrhage safety and efficacy: a protocol for a randomized, controlled, multicenter study (CRRICH Trial).

Jing Wang,Jianwen Guo,Rongming Lin,Haijun Li,Qixin Zhang,Liling Zeng

doi:10.1186/s40064-016-3136-y

Jing Wang, Jianwen Guo + Show 4 more

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https://doi.org/10.1186/s40064-016-3136-y

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Journal: SpringerPlus	Publication Date: Sep 1, 2016
Citations: 2	License type: CC BY 4.0

Affiliation: Guangzhou University of Chinese Medicine

Abstract

Background Hypertensive intracerebral hemorrhage (HICH) is one of the most devastating forms of stroke. Currently, no specific therapies for HICH except general medical care. However, in China, medicine of promoting blood circulation (PBC) and removing blood stasis (RBS) are widely and efficiently used to treat HICH and become a potentially effective treatment for the secondary effects of HICH to alleviate brain injury, accelerate neuronal recovery, and improve the prognosis. In order to evaluate the safety and effect of PBC and RBS herbal drugs, we design a prospective, randomized, open, double-blind controlled clinical trial on the hematoma enlargement in HICH patients treating with PBC and RBS herbal medicine within 6 h time window from the symptom onset.Methods/designA multicenter, three-group, prospective, randomized, double-blinded and placebo-controlled clinical trial. Patients aged 18 or older with HICH confirmed by CT scan within 6 h from the onset are included. 360 patients will be randomized to 3 groups (PBC & RBS & Placebo) within 6 h of ictus. Stratified block randomization is undertaken using a sequentially numbered and opaque envelope. All subjects must take medicine within 6 h of ictus and have another CT scan at about 24 h to confirm hematoma expansion. A postal questionnaire to the patients to evaluate their recorvery at 3 months. Primary outcome is the percent change in the volume of hematoma at 24 h. Secondary outcomes include: mortality, disability, serious adverse events, etc.ConclusionsThe CRRICH Trial is expected to confirm the safety and effect of acute intracerebral hemorrhage treated within 6 h of ictus with “RBS” therapy and to determine whether the traditional therapy can cause hematoma growth after intracerebral hemorrhage.DiscussionsThis is the first prospective, multicenter, randomized, placebo-controlled clinical trial to investigate herbal medicine whether can induce the incidence of hematoma enlargement of AICH patient within the 6 h time window from onset. We need the data to keep the herbal clinical usage safety. Trial registration clinicaltrials.gov: NCT01918722

Highlights

Hypertensive intracerebral hemorrhage (HICH) is one of the most devastating forms of stroke
The CRRICH Trial is expected to confirm the safety and effect of acute intracerebral hemorrhage treated within 6 h of ictus with “removing blood stasis (RBS)” therapy and to determine whether the traditional therapy can cause hematoma growth after intracerebral hemorrhage
The aim of this study is to evaluate the safety and effect of acute intracerebral hemorrhage (AICH) treated with “RBS” therapy and to determine whether the traditional therapy can cause hematoma growth after intracerebral hemorrhage

Summary

Introduction

Hypertensive intracerebral hemorrhage (HICH) is one of the most devastating forms of stroke. In order to evaluate the safety and effect of PBC and RBS herbal drugs, we design a prospective, randomized, open, double-blind controlled clinical trial on the hematoma enlargement in HICH patients treating with PBC and RBS herbal medicine within 6 h time window from the symptom onset. HICH is one of the most devastating forms of stroke which is a main cause of death and disability around the world (Roach et al 2005), playing a significant part in morbidity and mortality worldwide (Qureshi et al 2009). Several reasons may be related to the hematoma enlargement in the early stage of ICH, including high blood pressure, “spot” sign of CT scan, sex, age, time window, anticoagulation drugs (Lim et al 2008). There have not been specific therapies or treatments preventing hematoma expansion and improve the outcome after ICH. It has been confirmed that neither mini-traumatic operation nor the present accessible medicine is proved to be the ideal treatment based on the available evidencebased medical researches (Morgenstern et al 2010; Mendelow et al 2013; Mayer et al 2008)

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