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New Acute Treatment for Stroke - The Effect of Remote PERconditioning

NCT00975962 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-06-23

No results posted yet for this study

Summary

This study is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early treatment. As the size of the effect is unknown, the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the size of a potential neuro-protective effect.

The aims of this study are:

1. To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations.
2. To estimate the size of the effect of remote perconditioning in combination with recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours of onset of symptoms.

Conditions

  • Acute Stroke

Interventions

DRUG

Actilyse

Actilyse according to guidelines without pretreatment with remote persconditioning

PROCEDURE

Thrombolysis + remote perconditioning

The rIPerC consists of 4 cycles of 5 minute total occlusion of blood flow to the non-paretic arm separated by 5 minutes of reperfusion. The occlusion is secured by inflating a standard blood pressure cuff to 25 mmHg above the systolic blood pressure. Written instruction on cuff inflation and paramedic's documentation of their procedure were written in a standard report which was turned over to a study nurse upon arrival to the hospital, and filed. The investigators were hence blinded to the prehospital rIPerC.

Sponsors & Collaborators

  • TRYG Foundation

    collaborator OTHER

  • Aase and Ejnar Danielsens Foundation

    collaborator OTHER

  • Danish National Research Foundation

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Grethe Andersen, M.D Doctor · Department of Neurology Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975962 on ClinicalTrials.gov