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Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00963976
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : February 28, 2012
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
Information provided by (Responsible Party):
Ken Butcher, University of Alberta

Tracking Information
First Submitted Date  ICMJE August 21, 2009
First Posted Date  ICMJE August 24, 2009
Last Update Posted Date February 28, 2012
Study Start Date  ICMJE January 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2009)
Hematoma expansion rates at 24 hours. [ Time Frame: 24 hours post randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial
Official Title  ICMJE Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE Drug: labetalol/hydralazine/enalapril
Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
Study Arms  ICMJE
  • Experimental: Target systolic BP < 150 mmHg
    Systolic blood pressure will be reduced to <150 mmHg within 1 hour of randomization.
    Intervention: Drug: labetalol/hydralazine/enalapril
  • Active Comparator: Target systolic BP < 180 mmHg
    Systolic blood pressure will be reduced, to <180 mmHg within 1 hour of randomization.
    Intervention: Drug: labetalol/hydralazine/enalapril
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2009)
74
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00963976
Other Study ID Numbers  ICMJE ICHADAPT513000128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ken Butcher, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • Heart and Stroke Foundation of Canada
  • Alberta Heritage Foundation for Medical Research
Investigators  ICMJE Not Provided
PRS Account University of Alberta
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP