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Weight Approximation in Stroke Before Thrombolysis (WAIST)

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Erlangen-Nürnberg Medical School

Additional 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
Study First Received: October 30, 2009
Last Updated: May 13, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 25, 2014