NCT00963976

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

4.9 years

First QC Date

August 21, 2009

Last Update Submit

February 24, 2012

Conditions

Intracerebral Hemorrhage

Keywords

StrokeHypertensionCerebral Blood FlowCT Perfusion

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization.

    2 hours post randomization

Secondary Outcomes (1)

  • Hematoma expansion rates at 24 hours.

    24 hours post randomization

Study Arms (2)

Target systolic BP < 150 mmHg

EXPERIMENTAL

Systolic blood pressure will be reduced to \<150 mmHg within 1 hour of randomization.

Drug: labetalol/hydralazine/enalapril

Target systolic BP < 180 mmHg

ACTIVE COMPARATOR

Systolic blood pressure will be reduced, to \<180 mmHg within 1 hour of randomization.

Drug: labetalol/hydralazine/enalapril

Interventions

labetalol/hydralazine/enalaprilDRUG

Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).

Target systolic BP < 150 mmHgTarget systolic BP < 180 mmHg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Acute primary ICH demonstrated with CT scan
  • Onset ≤ 24 h prior to randomization

You may not qualify if:

  • 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
  • Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine \>160 μmol/l)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, T6G2B7, Canada

Location

Grey Nuns Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

University of Ottawa

Ottawa, Ontario, Canada

Location

Related Publications (6)

  • 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.

    PMID: 31131671DERIVED

  • 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.

    PMID: 25700288DERIVED

  • 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.

    PMID: 25147326DERIVED

  • 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.

    PMID: 24692481DERIVED

  • 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.

    PMID: 23391776DERIVED

  • 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.

    PMID: 20536619DERIVED

MeSH Terms

Conditions

Cerebral HemorrhageStrokeHypertension

Interventions

Labetalol

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2009

First Posted

August 24, 2009

Study Start

January 1, 2007

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

CA(4)