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Weight Approximation in Stroke Before Thrombolysis (WAIST)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Martin Köhrmann, University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006434
First Posted: November 2, 2009
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Martin Köhrmann, University of Erlangen-Nürnberg Medical School
  Purpose

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.


Condition Intervention
Stroke Other: Recording of body weight estimations, approximations and tPA dose

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Martin Köhrmann, University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Dose dependent efficacy of thrombolysis. Modified Rankin Score after 3 Months. [ Time Frame: 90 days ]
  • Dose dependent safety of thrombolysis [ Time Frame: 90 days ]

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

Estimated Enrollment: 800
Study Start Date: April 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients receiving intravenous thrombolysis for acute ischemic stroke.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • common exclusion criteria for intravenous thrombolysis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006434


Contacts
Contact: Martin Köhrmann, MD +49-9131-8533001 martin.koehrmann@uk-erlangen.de
Contact: Lorenz Breuer, MD +49-9131-8533001 lorenz.breuer@uk-erlangen.de

Locations
Germany
Universityhospital Erlangen, Dept. of Neurology Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Martin Köhrmann, MD    +49-9131-8533001    martin.koehrmann@uk-erlangen.de   
Contact: Lorenz Breuer, MD    +49-9131-8533001    lorenz.breuer@uk-erlangen.de   
Sub-Investigator: Lorenz Breuer, MD         
Sub-Investigator: Hagen B Huttner, MD         
Sub-Investigator: Tim Nowe, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Martin Köhrmann, MD Universityhospital Erlangen; Dept. of Neurology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Köhrmann, MD, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01006434     History of Changes
Other Study ID Numbers: DE-ER-WAIST
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Martin Köhrmann, University of Erlangen-Nürnberg Medical School:
Stroke
Thrombolysis

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases