Weight Approximation in Stroke Before Thrombolysis (WAIST)

This study is currently recruiting participants.
Verified May 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
Martin Köhrmann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01006434
First received: October 30, 2009
Last updated: May 13, 2013
Last verified: May 2013

October 30, 2009
May 13, 2013
April 2008
December 2013   (final data collection date for primary outcome measure)
  • Dose dependent efficacy of thrombolysis. Modified Rankin Score after 3 Months. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Dose dependent safety of thrombolysis [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01006434 on ClinicalTrials.gov Archive Site
  • Availability and accuracy of body weight information. [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • Accuracy of body weight estimations (medical personnel, patients) [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • Dosage errors of tPA [ Time Frame: 24 h ] [ Designated as safety issue: No ]
Same as current
Not Provided
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Weight Approximation in Stroke Before Thrombolysis
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All patients receiving intravenous thrombolysis for acute ischemic stroke.

Stroke
Other: Recording of body weight estimations, approximations and tPA dose
Body weight estimation, patients are weighed, actual tPA dose is recorded
  • Thrombolysis group (Pilot phase)
    Patients receiving intravenous thrombolysis for acute ischemic stroke. Pilot phase (100 Patients).
    Intervention: Other: Recording of body weight estimations, approximations and tPA dose
  • Thrombolysis group
    Patients receiving intravenous thrombolysis for acute ischemic stroke.
    Intervention: Other: Recording of body weight estimations, approximations and tPA dose
Breuer L, Nowe T, Huttner HB, Blinzler C, Kollmar R, Schellinger PD, Schwab S, Köhrmann M. Weight approximation in stroke before thrombolysis: the WAIST-Study: a prospective observational "dose-finding" study. Stroke. 2010 Dec;41(12):2867-71. doi: 10.1161/STROKEAHA.110.578062. Epub 2010 Nov 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • common exclusion criteria for intravenous thrombolysis
Both
18 Years and older
No
Contact: Martin Köhrmann, MD +49-9131-8533001 martin.koehrmann@uk-erlangen.de
Contact: Lorenz Breuer, MD +49-9131-8533001 lorenz.breuer@uk-erlangen.de
Germany
 
NCT01006434
DE-ER-WAIST
No
Martin Köhrmann, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
Principal Investigator: Martin Köhrmann, MD Universityhospital Erlangen; Dept. of Neurology
University of Erlangen-Nürnberg Medical School
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP