Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT)

February 24, 2012 updated by: Ken Butcher, University of Alberta

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

Completed

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G2B7
        • University of Alberta
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Hospital
    • Ontario
      • Ottawa, Ontario, Canada
        • University of Ottawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
2 hours post randomization

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria

August 21, 2009

First Posted (ESTIMATE)

August 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 24, 2012

Last Verified

February 1, 2012

More Information

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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