Inventi Impact: Clinical Research

Inventi:pcr/20843/16

Clinical Re-Evaluation of Removing Blood Stasis Therapy in Treating Acute Intracerebral\nHemorrhage Safety and Efficacy: A Protocol for a Randomized, Controlled, Multicenter Study\n(CRRICH Trial)

Background: Hypertensive intracerebral hemorrhage (HICH) is one of the most\ndevastating forms of stroke. Currently, no specific therapies for HICH except general\nmedical care. However, in China, medicine of promoting blood circulation (PBC) and\nremoving blood stasis (RBS) are widely and efficiently used to treat HICH and become\na potentially effective treatment for the secondary effects of HICH to alleviate brain\ninjury, accelerate neuronal recovery, and improve the prognosis. In order to evaluate\nthe safety and effect of PBC and RBS herbal drugs, we design a prospective, randomized,\nopen, double-blind controlled clinical trial on the hematoma enlargement in\nHICH patients treating with PBC and RBS herbal medicine within 6 h time window from\nthe symptom onset.\nMethods/design: A multicenter, three-group, prospective, randomized, doubleblinded\nand placebo-controlled clinical trial. Patients aged 18 or older with HICH\nconfirmed by CT scan within 6 h from the onset are included. 360 patients will be\nrandomized to 3 groups (PBC & RBS & Placebo) within 6 h of ictus. Stratified block\nrandomization is undertaken using a sequentially numbered and opaque envelope.\nAll subjects must take medicine within 6 h of ictus and have another CT scan at about\n24 h to confirm hematoma expansion. A postal questionnaire to the patients to evaluate\ntheir recorvery at 3 months. Primary outcome is the percent change in the volume\nof hematoma at 24 h. Secondary outcomes include: mortality, disability, serious adverse\nevents, etc.\nConclusions: The CRRICH Trial is expected to confirm the safety and effect of acute\nintracerebral hemorrhage treated within 6 h of ictus with ââ?¬Å?RBSââ?¬Â therapy and to determine\nwhether the traditional therapy can cause hematoma growth after intracerebral\nhemorrhage.\nDiscussions: This is the first prospective, multicenter, randomized, placebo-controlled\nclinical trial to investigate herbal medicine whether can induce the incidence of hematoma\nenlargement of AICH patient within the 6 h time window from onset. We need\nthe data to keep the herbal clinical usage safety.