Weight Approximation in Stroke Before Thrombolysis

NCT01006434 | Unknown

• 1 other identifier: DE-ER-WAIST
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Thrombolysis

Outcome Measures

Primary Outcomes (2)

• Dose dependent efficacy of thrombolysis. Modified Rankin Score after 3 Months.

  90 days

• Dose dependent safety of thrombolysis

  90 days

Secondary Outcomes (3)

• Availability and accuracy of body weight information.

  24 h

• Accuracy of body weight estimations (medical personnel, patients)

  24 h

• Dosage errors of tPA

  24 h

Study Arms (2)

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

Thrombolysis group

Patients receiving intravenous thrombolysis for acute ischemic stroke.

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

Interventions

Recording of body weight estimations, approximations and tPA dose OTHER

Body weight estimation, patients are weighed, actual tPA dose is recorded

Thrombolysis group; Thrombolysis group (Pilot phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients receiving intravenous thrombolysis for acute ischemic stroke.

You may qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universityhospital Erlangen, Dept. of Neurology

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (1)

• Breuer L, Nowe T, Huttner HB, Blinzler C, Kollmar R, Schellinger PD, Schwab S, Kohrmann 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.

  PMID: 21071723 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martin Köhrmann, MD

  Universityhospital Erlangen; Dept. of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Köhrmann, MD

CONTACT

+49-9131-8533001; martin.koehrmann@uk-erlangen.de

Lorenz Breuer, MD

CONTACT

+49-9131-8533001; lorenz.breuer@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: April 1, 2008
• Primary Completion: December 1, 2013
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

DE (1)