Ischemic StrokeEMISTPANCT01331200
Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA)
An observational study of Ischemic Stroke, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to study the safety and feasibility of mobilization of acute ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients experiencing acute ischemic stroke who receive intravenous tissue plasminogen activator (IV-tPA) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tPA infusion.
Who may be able to join
- Patients post acute ischemic stroke that have been treated with intravenous tissue plasminogen activator (IV-tPA)
- 13 hours have elapsed since initiation of intravenous TPA infusion
- Patients are hemodynamically stable (e.g., not on vasopressors or antihypertensive drips or requiring multiple IV PRN boluses of either medication)
- Patient is able to actively engage in the evaluation
Who cannot join
- Patients with femoral sheaths or recent removal of femoral sheaths
- Patients who are hemodynamically unstable, with active bleeding from lines, catheters, INT site or wounds or angioedema
- Electrocardiogram showing (HR>100)
- Vital signs (HR > 100, SBP <90 or >180, DBP <70 or > 105)
- Patients experiencing marked diaphoresis, facial pallor, intense anxious or painful facial expression (especially in aphasic patients)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.
The purpose of this study is to study the safety and feasibility of mobilization of acute ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.
Read the detailed description
Abstract:
Introduction
Historical precedence exists demonstrating that early intensive care unit (ICU) mobilization of patients reduces risks of complication and lengths of hospital stay, and may improve long-term health status of patients.
Objective
To determine the safety of early mobilization by physical and/or occupational therapy in acute ischemic stroke patients within 24-hours of IV-tPA infusion and to examine if early mobilization leads to shortened ICU and hospital length of stay.
Methods
Prospective study of incidence of adverse response and functional mobility status of study patients mobilized by occupational and/or physical therapy between 12- 24 hours after IV-tPA infusion with comparison of ICU and hospital Length of Stay data between study group and pre-study patients who were mobilized by occupational and/or physical therapy services at no pre-determined time after IV-tPA infusion. Additionally, patients will be contacted by study personnel approximately 3 to 5-days and 30-days post-infusion for completion of Modified Rankin Scale stroke disability survey as follow up of stroke recovery.
Setting
Medical and surgical intensive care units at Mayo Clinic Florida.
Patients
All patients with acute ischemic stroke who receive intravenous tissue plasminogen activator (IV-tPA) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tPA infusion.
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, tissue plasminogen activator, early mobilization, patient safety, length of stay
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Patient Disability post-TPA Infusion.
Study participants will be contacted at approximately 3 to 5-days and 30-days post-IV tPA infusion to capture level of disability by use of Modified Rankin Scale.
Measured: 30-days post-IV tPA infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Scott M Arnold, PT, Principal investigator, Mayo ClinicOlivia S Chavez, MS, OTR/L, Principal investigator, Mayo ClinicWilliam D Freeman, MD, Principal investigator, Mayo ClinicJames Meschia, MD, Principal investigator, Mayo ClinicLesia Mooney, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331200
- Sponsor's protocol ID
- 10-007822
- Acronym
- EMISTPA
- Status last verified
- Feb 2013
- First submitted
- 4 Feb 2011
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.
- ClinicalTrials.gov ID
- NCT01331200
- Acronym / sponsor ID
- EMISTPA / 10-007822
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, tissue plasminogen activator, early mobilization, patient safety, length of stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the safety and feasibility of mobilization of acute ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.
Detailed description
Abstract:
Introduction
Historical precedence exists demonstrating that early intensive care unit (ICU) mobilization of patients reduces risks of complication and lengths of hospital stay, and may improve long-term health status of patients.
Objective
To determine the safety of early mobilization by physical and/or occupational therapy in acute ischemic stroke patients within 24-hours of IV-tPA infusion and to examine if early mobilization leads to shortened ICU and hospital length of stay.
Methods
Prospective study of incidence of adverse response and functional mobility status of study patients mobilized by occupational and/or physical therapy between 12- 24 hours after IV-tPA infusion with comparison of ICU and hospital Length of Stay data between study group and pre-study patients who were mobilized by occupational and/or physical therapy services at no pre-determined time after IV-tPA infusion. Additionally, patients will be contacted by study personnel approximately 3 to 5-days and 30-days post-infusion for completion of Modified Rankin Scale stroke disability survey as follow up of stroke recovery.
Setting
Medical and surgical intensive care units at Mayo Clinic Florida.
Patients
All patients with acute ischemic stroke who receive intravenous tissue plasminogen activator (IV-tPA) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tPA infusion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing acute ischemic stroke who receive intravenous tissue plasminogen activator (IV-tPA) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tPA infusion.
Key inclusion criteria (4 listed)
- Patients post acute ischemic stroke that have been treated with intravenous tissue plasminogen activator (IV-tPA)
- 13 hours have elapsed since initiation of intravenous TPA infusion
- Patients are hemodynamically stable (e.g., not on vasopressors or antihypertensive drips or requiring multiple IV PRN boluses of either medication)
- Patient is able to actively engage in the evaluation
Key exclusion criteria (5 listed)
- Patients with femoral sheaths or recent removal of femoral sheaths
- Patients who are hemodynamically unstable, with active bleeding from lines, catheters, INT site or wounds or angioedema
- Electrocardiogram showing (HR>100)
- Vital signs (HR > 100, SBP <90 or >180, DBP <70 or > 105)
- Patients experiencing marked diaphoresis, facial pallor, intense anxious or painful facial expression (especially in aphasic patients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Patient Disability post-TPA Infusion.
Time frame: 30-days post-IV tPA infusion
Study participants will be contacted at approximately 3 to 5-days and 30-days post-IV tPA infusion to capture level of disability by use of Modified Rankin Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott M Arnold, PT principal investigator
Mayo Clinic
Olivia S Chavez, MS, OTR/L principal investigator
Mayo Clinic
William D Freeman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Patient Disability post-TPA Infusion. (time frame: 30-days post-IV tPA infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.