title: 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).
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
  A 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: No. 1 Neurology Department, The 2nd Teaching Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincal Hospital of Chinese Medicine, Guangdong Province Key Laboratory of Emergency medicine of TCM., 111 Da'de Road, Yuexiu District, Guangzhou, Guangdong China.
authors.forename: Liling
authors.identifier: 0000-0001-7023-3481
authors.initials: L
authors.lastname: Zeng
authors.affiliation: No. 1 Neurology Department, The 2nd Teaching Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincal Hospital of Chinese Medicine, Guangdong Province Key Laboratory of Emergency medicine of TCM., 111 Da'de Road, Yuexiu District, Guangzhou, Guangdong China.
authors.forename: Jianwen
authors.initials: J
authors.lastname: Guo
authors.affiliation: Neurology Department, Shenzhen Longhua New District Center Hospita, Shenzhen, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.affiliation: No. 1 Neurology Department, The 2nd Teaching Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincal Hospital of Chinese Medicine, Guangdong Province Key Laboratory of Emergency medicine of TCM., 111 Da'de Road, Yuexiu District, Guangzhou, Guangdong China.
authors.forename: Qixin
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: No. 1 Neurology Department, The 2nd Teaching Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincal Hospital of Chinese Medicine, Guangdong Province Key Laboratory of Emergency medicine of TCM., 111 Da'de Road, Yuexiu District, Guangzhou, Guangdong China.
authors.forename: Haijun
authors.initials: H
authors.lastname: Li
authors.affiliation: No. 1 Neurology Department, The 2nd Teaching Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincal Hospital of Chinese Medicine, Guangdong Province Key Laboratory of Emergency medicine of TCM., 111 Da'de Road, Yuexiu District, Guangzhou, Guangdong China.
authors.forename: Rongming
authors.initials: R
authors.lastname: Lin
keywords: Clinical trial; Intracerebral hemorrhage; Promoting blood circulation; Removing blood stasis; Traditional Chinese medicine