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The intracerebral hemorrhage acutely decreasing arterial pressure trial II (ICH ADAPT II) protocol
- Source :
- BMC Neurology, Vol 17, Iss 1, Pp 1-6 (2017), BMC Neurology
- Publication Year :
- 2017
- Publisher :
- BMC, 2017.
-
Abstract
- Background Aggressively 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. Methods The Intracerebral Hemorrhage Acutely Decreasing Blood Pressure Trial 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 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. Discussion This 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 registration This study is registered with clinicaltrials.gov (NCT02281838, first received October 29, 2014). Electronic supplementary material The online version of this article (doi:10.1186/s12883-017-0884-4) contains supplementary material, which is available to authorized users.
- Subjects :
- Blood Pressure
DWI
030204 cardiovascular system & hematology
Intracerebral Hemorrhage
lcsh:RC346-429
Lesion
Study Protocol
03 medical and health sciences
0302 clinical medicine
Hematoma
Humans
Medicine
Arterial Pressure
cardiovascular diseases
Stroke
lcsh:Neurology. Diseases of the nervous system
Cerebral Hemorrhage
Intracerebral hemorrhage
medicine.diagnostic_test
business.industry
Magnetic resonance imaging
General Medicine
medicine.disease
Magnetic Resonance Imaging
Clinical Trial
Clinical trial
Diffusion Magnetic Resonance Imaging
Blood pressure
Cerebral blood flow
Research Design
Cerebrovascular Circulation
Anesthesia
Hypertension
Neurology (clinical)
medicine.symptom
business
030217 neurology & neurosurgery
MRI
Subjects
Details
- Language :
- English
- ISSN :
- 14712377
- Volume :
- 17
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMC Neurology
- Accession number :
- edsair.doi.dedup.....ce55c4ff514a70b8d3d45463651f0969