MedTrace Logo

Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting

NCT00585351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-01-16

Study results available
· View outcomes & findings →

Summary

We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care to participate in this research study to test the following: 1) To test whether it is possible to go through all the procedures necessary to start a study, including an informed consent, before the patient is transferred by helicopter to Iowa City. 2)To test a low risk medication called, Ranitidine, that might lower the chances of developing chemical pneumonitis (irritation of the lungs by stomach contents), a fairly common complication in patients that have had a stroke. Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 milligrams (mg)) or placebo (normal saline).

Conditions

Interventions

DRUG

Ranitidine

50 mg single dose injection of Ranitidine

DRUG

Placebo

50 mg single dose injection of normal saline (placebo)

OTHER

Advanced notification

Advanced notification of study via faxed consent to local Emergency Room (ER)

OTHER

No advanced notification

No advanced notification of study via faxed consent to local Emergency Room (ER)

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Enrique C Leira, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00585351 on ClinicalTrials.gov