Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT01006434
Status:
UNKNOWN
Last Update Posted:
2013-05-14
First Post:
2009-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Approximation in Stroke Before Thrombolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2009-10-30', 'studyFirstSubmitQcDate': '2009-11-01', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose dependent efficacy of thrombolysis. Modified Rankin Score after 3 Months.', 'timeFrame': '90 days'}, {'measure': 'Dose dependent safety of thrombolysis', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Availability and accuracy of body weight information.', 'timeFrame': '24 h'}, {'measure': 'Accuracy of body weight estimations (medical personnel, patients)', 'timeFrame': '24 h'}, {'measure': 'Dosage errors of tPA', 'timeFrame': '24 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Thrombolysis'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '21071723', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients receiving intravenous thrombolysis for acute ischemic stroke.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients receiving intravenous thrombolysis with tPA for acute ischemic stroke\n\nExclusion Criteria:\n\n* common exclusion criteria for intravenous thrombolysis'}, 'identificationModule': {'nctId': 'NCT01006434', 'acronym': 'WAIST', 'briefTitle': 'Weight Approximation in Stroke Before Thrombolysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'orgStudyIdInfo': {'id': 'DE-ER-WAIST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thrombolysis group (Pilot phase)', 'description': 'Patients receiving intravenous thrombolysis for acute ischemic stroke. Pilot phase (100 Patients).', 'interventionNames': ['Other: Recording of body weight estimations, approximations and tPA dose']}, {'label': 'Thrombolysis group', 'description': 'Patients receiving intravenous thrombolysis for acute ischemic stroke.', 'interventionNames': ['Other: Recording of body weight estimations, approximations and tPA dose']}], 'interventions': [{'name': 'Recording of body weight estimations, approximations and tPA dose', 'type': 'OTHER', 'description': 'Body weight estimation, patients are weighed, actual tPA dose is recorded', 'armGroupLabels': ['Thrombolysis group', 'Thrombolysis group (Pilot phase)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Köhrmann, MD', 'role': 'CONTACT', 'email': 'martin.koehrmann@uk-erlangen.de', 'phone': '+49-9131-8533001'}, {'name': 'Lorenz Breuer, MD', 'role': 'CONTACT', 'email': 'lorenz.breuer@uk-erlangen.de', 'phone': '+49-9131-8533001'}, {'name': 'Lorenz Breuer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hagen B Huttner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tim Nowe, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universityhospital Erlangen, Dept. of Neurology', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Martin Köhrmann, MD', 'role': 'CONTACT', 'email': 'martin.koehrmann@uk-erlangen.de', 'phone': '+49-9131-8533001'}, {'name': 'Lorenz Breuer, MD', 'role': 'CONTACT', 'email': 'lorenz.breuer@uk-erlangen.de', 'phone': '+49-9131-8533001'}], 'overallOfficials': [{'name': 'Martin Köhrmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universityhospital Erlangen; Dept. of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Martin Köhrmann', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}