- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00963976
Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT)
Rationale: Management of blood pressure (BP) in the acute phase of intracerebral hemorrhage (ICH) remains controversial. Although it has been established that there is a transient moderate reduction of perihematoma cerebral blood flow (CBF) in acute ICH, the effect of BP treatment is unknown. The potential for exacerbation of CBF has precluded routine aggressive BP reduction.
Aim and Hypothesis: The primary study aim is to demonstrate the feasibility and safety of acute BP reduction to < 150 mmHg systolic using a standardized protocol in ICH patients. It is hypothesized that CTP will not demonstrate evidence of perihematoma ischemia following acute BP reduction.
Design: ICH ADAPT is a randomized blinded endpoint trial. Acutely hypertensive ICH patients are randomized to a target systolic BP of < 150 mmHg or < 180 mmHg. Patients are treated with intravenous (IV) labetalol/hydralazine/enalapril.
Study Outcomes: The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. Secondary outcomes include the difference in BP at 1 and 2 hours post-randomization in the two treatment groups and hematoma expansion rates at 24 hours.
Discussion: ICH ADAPT is the only randomized trial designed specifically to identify any hemodynamic changes in the perihematoma region secondary to aggressive BP management. The results of this trial will facilitate ongoing and future studies aimed at determining the efficacy of rapid BP reduction in acute ICH.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada
- University of Calgary
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Edmonton, Alberta, Canada, T6G2B7
- University of Alberta
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Edmonton, Alberta, Canada, T6L 5X8
- Grey Nuns Hospital
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-
Ontario
-
Ottawa, Ontario, Canada
- University of Ottawa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥18 years
- Acute primary ICH demonstrated with CT scan
- Onset ≤ 24 h prior to randomization
Exclusion Criteria:
- Contraindication to BP reduction i.e., severe arterial stenosis or high-grade stenotic valvular heart disease
- Indication for urgent BP reduction i.e., hypertensive encephalopathy, or aortic dissection
- Definite evidence that the ICH is secondary to underlying cerebral or vascular pathology, i.e., AVM, aneurysm, tumour, trauma, vasculitis, or hemorrhagic transformation of an ischemic infarct
- Previous ischemic stroke within 30 days of current event NB: Prior ICH is not an exclusion criterion
- Planned surgical resection of hematoma NB: Extraventricular Drain placement is not an exclusion criterion
- Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine >160 μmol/l)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Target systolic BP < 150 mmHg
Systolic blood pressure will be reduced to <150 mmHg within 1 hour of randomization.
|
Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
|
ACTIVE_COMPARATOR: Target systolic BP < 180 mmHg
Systolic blood pressure will be reduced, to <180 mmHg within 1 hour of randomization.
|
Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization.
Time Frame: 2 hours post randomization
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2 hours post randomization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hematoma expansion rates at 24 hours.
Time Frame: 24 hours post randomization
|
24 hours post randomization
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Klahr AC, Kosior JC, Dowlatshahi D, Buck BH, Beaulieu C, Gioia LC, Kalashyan H, Wilman AH, Jeerakathil T, Emery DJ, Shuaib A, Butcher KS. Lower Blood Pressure Is Not Associated With Decreased Arterial Spin Labeling Estimates of Perfusion in Intracerebral Hemorrhage. J Am Heart Assoc. 2019 Jun 4;8(11):e010904. doi: 10.1161/JAHA.118.010904.
- McCourt R, Gould B, Kate M, Asdaghi N, Kosior JC, Coutts S, Hill MD, Demchuk A, Jeerakathil T, Emery D, Butcher KS. Blood-brain barrier compromise does not predict perihematoma edema growth in intracerebral hemorrhage. Stroke. 2015 Apr;46(4):954-60. doi: 10.1161/STROKEAHA.114.007544. Epub 2015 Feb 19.
- Gould B, McCourt R, Gioia LC, Kate M, Hill MD, Asdaghi N, Dowlatshahi D, Jeerakathil T, Coutts SB, Demchuk AM, Emery D, Shuaib A, Butcher K; ICH ADAPT Investigators. Acute blood pressure reduction in patients with intracerebral hemorrhage does not result in borderzone region hypoperfusion. Stroke. 2014 Oct;45(10):2894-9. doi: 10.1161/STROKEAHA.114.005614. Epub 2014 Aug 21.
- McCourt R, Gould B, Gioia L, Kate M, Coutts SB, Dowlatshahi D, Asdaghi N, Jeerakathil T, Hill MD, Demchuk AM, Buck B, Emery D, Butcher K; ICH ADAPT Investigators. Cerebral perfusion and blood pressure do not affect perihematoma edema growth in acute intracerebral hemorrhage. Stroke. 2014 May;45(5):1292-8. doi: 10.1161/STROKEAHA.113.003194. Epub 2014 Apr 1.
- Butcher KS, Jeerakathil T, Hill M, Demchuk AM, Dowlatshahi D, Coutts SB, Gould B, McCourt R, Asdaghi N, Findlay JM, Emery D, Shuaib A; ICH ADAPT Investigators. The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial. Stroke. 2013 Mar;44(3):620-6. doi: 10.1161/STROKEAHA.111.000188. Epub 2013 Feb 7.
- Butcher K, Jeerakathil T, Emery D, Dowlatshahi D, Hill MD, Sharma M, Buck B, Findlay M, Lee TY, Demchuk AM. The Intracerebral Haemorrhage Acutely Decreasing Arterial Pressure Trial: ICH ADAPT. Int J Stroke. 2010 Jun;5(3):227-33. doi: 10.1111/j.1747-4949.2010.00431.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Cerebral Hemorrhage
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin-Converting Enzyme Inhibitors
- Sympathomimetics
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Enalapril
- Labetalol
- Hydralazine
Other Study ID Numbers
- ICHADAPT513000128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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