Weight Approximation in Stroke Before Thrombolysis

NCT ID: NCT01006434

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Thrombolysis group (Pilot phase)

Patients receiving intravenous thrombolysis for acute ischemic stroke. Pilot phase (100 Patients).

Recording of body weight estimations, approximations and tPA dose

Intervention Type: OTHER

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

Thrombolysis group

Patients receiving intravenous thrombolysis for acute ischemic stroke.

Recording of body weight estimations, approximations and tPA dose

Intervention Type: OTHER

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

Interventions

Recording of body weight estimations, approximations and tPA dose

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Martin Köhrmann

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Köhrmann, MD

Role: PRINCIPAL_INVESTIGATOR

Universityhospital Erlangen; Dept. of Neurology

Locations

Universityhospital Erlangen, Dept. of Neurology

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Martin Köhrmann, MD

Role: CONTACT

martin.koehrmann@uk-erlangen.de

+49-9131-8533001

Lorenz Breuer, MD

Role: CONTACT

lorenz.breuer@uk-erlangen.de

+49-9131-8533001

Facility Contacts

Martin Köhrmann, MD

Role: primary

martin.koehrmann@uk-erlangen.de

+49-9131-8533001

Lorenz Breuer, MD

Role: backup

lorenz.breuer@uk-erlangen.de

+49-9131-8533001

References

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.

Reference Type: DERIVED

PMID: 21071723 (View on PubMed)

Other Identifiers

DE-ER-WAIST

Identifier Type: -

Identifier Source: org_study_id