The intracerebral hemorrhage acutely decreasing arterial pressure trial II ICH ADAPT II protocolReport as inadecuate

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BMC Neurology

, 17:100

Cerebrovascular disease and stroke


BackgroundAggressively lowering blood pressure BP in acute intracerebral hemorrhage ICH may improve outcome. Although there is no evidence that BP reduction changes cerebral blood flow, retrospective magnetic resonance imaging MRI studies have demonstrated sub-acute ischemic lesions in ICH patients. The primary aim of this study is to assess ischemic lesion development in patients randomized to two different BP treatment strategies. We hypothesize aggressive BP reduction is not associated with ischemic injury after ICH.

MethodsThe I ntrac erebral H emorrhage A cutely D ecreasing B lood P ressure T rial II ICH ADAPT II is a phase II multi-centre randomized open-label, blinded-endpoint trial. Acute ICH patients N = 270 are randomized to a systolic blood pressure SBP target of <140 or <180 mmHg. Acute ICH patients within 6 h of onset and two SBP measurements ≥140 mmHg recorded >2 mins apart qualify. SBP is managed with a pre-defined treatment protocol. Patients undergo MRI at 48 h, Days 7 and 30, with clinical assessment at Day 30 and 90. The primary outcome is diffusion weighted imaging DWI lesion frequency at 48 h. Secondary outcomes include cumulative DWI lesion rate frequency within 30 days, absolute hematoma growth, prediction of DWI lesion incidence, 30-day mortality rates, day 90 functional outcome, and cognitive status.

DiscussionThis trial will assess the impact of hypertensive therapies on physiological markers of ischemic injury. The findings of this study will provide evidence for the link, or lack thereof, between BP reduction and ischemic injury in ICH patients.

Trial registrationThis study is registered with  NCT02281838, first received October 29, 2014.

KeywordsBlood Pressure Intracerebral Hemorrhage DWI MRI Stroke Clinical Trial AbbreviationsADCApparent diffusion coefficient

ASLArterial spin labeling

ATACH IIAntihypertensive treatment of acute cerebral hemorrhage II

BPBlood pressure

CBFCerebral blood flow

CTComputed tomography

DSMBData safety monitoring body

DWIDiffusion-weighted imaging

FLAIRFluid-attenuated inverse recovery

GCSGlasgow coma scale

ICH ADAPT IIIntracerebral Hemorrhage Acutely Decreasing Blood Pressure Trial II

ICHIntracerebral hemorrhage

INTERACT IIIntensive blood pressure reduction in acute cerebral hemorrhage II

MAPMean arterial pressure

MoCAMontreal cognitive assessment

MRIMagnetic resonance imaging

mRSModified Rankin scale

NIHSSNational Institutes of Health Stroke Scale

PROBEProspective, randomized, open-label study with blinded-evaluation

SAESerious adverse events

SBPSystolic blood pressure

SWISusceptibility Weighted Imaging

Electronic supplementary materialThe online version of this article doi:10.1186-s12883-017-0884-4 contains supplementary material, which is available to authorized users.

Author: Laura Gioia - Ana Klahr - Mahesh Kate - Brian Buck - Dariush Dowlatshahi - Thomas Jeerakathil - Derek Emery - Kenneth Butc


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