Weight Approximation in Stroke Before Thrombolysis (WAIST)

May 13, 2013 updated by: Martin Köhrmann, University of Erlangen-Nürnberg Medical School

Thrombolysis using Alteplase (tPA) is still the only approved specific therapy for acute ischemic stroke (AIS). Current guidelines in western countries recommend an tPA dose of 0.9mg/kg up to a maximum dose of 90mg for patients weighing more than 100kg. However, larger dose-finding rtPA trials for intravenous thrombolysis in AIS are missing. Based on results from research on myocardial infarction only a few open label studies with low case rates were initiated to evaluate the optimal dose for tPA in cerebral ischemia. These studies suggested a narrow therapeutic range with decreased efficacy in lower dosages and an increased risk for thrombolysis related intracerebral hemorrhage (ICH) at doses above 0.95mg/kg. The ECASS-1 trial which used a dosage of 1.1mg/kg rt-PA showed significantly higher rate of large parenchymal hemorrhages compared to trials using 0.9mg/kg. Therefore accurate dosing is crucial. In the acute phase two aspects complicate rtPA dosing in AIS: First, unlike in other diseases many stroke patients are unable to communicate information on their body weight (BW) because of their stroke symptoms (e.g. aphasia, decreased consciousness). In addition motor symptoms prohibit easy weighing procedures in many patients. Second, the ultra-early and narrow time window for treatment does not allow time loss to weigh each patient in the emergency situation. Therefore routinely the attending physician has to make a visual estimation of the patient's BW. This may be inaccurate and may cause dosing errors which has been shown for other weight based emergency medication. There is little data on tPA-dosing errors in stroke patients and prospective data are lacking. The aim of our study is to evaluate availability of BW-information, accuracy of estimations and final dosing of tPA in a routine clinical setting. Therefore the investigators evaluate different sources of body weight estimations and also compare visual estimation with recently proposed anthropometric measurements for body weight approximation. Finally, impact of dosing errors on safety and efficacy are analyzed.

The initial phase will consist of 100 enrolled patients as a pilot phase for further power calculations. Based on the results of the pilot phase enrollment will continue. The envisioned inclusion target is up to 800 patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

800

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

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universityhospital Erlangen, Dept. of Neurology
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lorenz Breuer, MD
        • Sub-Investigator:
          • Hagen B Huttner, MD
        • Sub-Investigator:
          • Tim Nowe, MD

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

Sampling Method

Non-Probability Sample

Study Population

All patients receiving intravenous thrombolysis for acute ischemic stroke.

Description

Inclusion Criteria:

  • all patients receiving intravenous thrombolysis with tPA for acute ischemic stroke

Exclusion Criteria:

  • common exclusion criteria for intravenous thrombolysis

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thrombolysis group (Pilot phase)
Patients receiving intravenous thrombolysis for acute ischemic stroke. Pilot phase (100 Patients).
Other: Recording of body weight estimations, approximations and tPA dose
Body weight estimation, patients are weighed, actual tPA dose is recorded
Thrombolysis group
Patients receiving intravenous thrombolysis for acute ischemic stroke.
Other: Recording of body weight estimations, approximations and tPA dose
Body weight estimation, patients are weighed, actual tPA dose is recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose dependent efficacy of thrombolysis. Modified Rankin Score after 3 Months.
Time Frame: 90 days
90 days
Dose dependent safety of thrombolysis
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Availability and accuracy of body weight information.
Time Frame: 24 h
24 h
Accuracy of body weight estimations (medical personnel, patients)
Time Frame: 24 h
24 h
Dosage errors of tPA
Time Frame: 24 h
24 h

Collaborators and Investigators

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

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Martin Köhrmann, MD, Universityhospital Erlangen; Dept. of Neurology

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

April 1, 2008

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

November 1, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-ER-WAIST

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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