Register on the prognosis of acute symptomatic seizures
Organizational Data
- DRKS-ID:
- DRKS00017811
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2019-08-13
- Last update in DRKS:
- 2024-04-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
PROSE register
URL of the study
No Entry
Brief summary in lay language
Acute symptomatic seizures are symptoms of an acute disturbance of the brain which can result directly from a damage to the brain itself (e.g., traumatic brain injury) or indirectly from conditions that affect the whole organism (e.g., hypoglycaemia). Depending on the individual situation, it may be reasonable to apply or not to apply drugs which lower the risk of further seizures ("antiseizure medication") for a short period of time (i.e., during the "acute phase"). As the risk of subsequent unprovoked seizures is low (10-years risk: <20%), a long-term antiseizure drug therapy is usually not necessary. However, until now, evidence on the risk of subsequent unprovoked seizures is limited, and relevant data were acquired several decades ago. With the aid of the PROSE register, we aim at, firstly, determining the risk of seizure relapse after an acute symptomatic first seizure that were treated according to current clinical guidelines. Secondly, we aim at identifying clinical variables associated with a higher or lower risk of seizure relapse. The results of the PROSE register will help clinicians in the future to give tailored therapeutic recommendations to their patients affected by acute symptomatic epileptic seizures.
Brief summary in scientific language
Acute symptomatic seizures (ASS) are symptoms of an acute disturbance of brain function. Following an operational definition, ASS occur in close temporal relationship to specific types of acute brain injury or systemic conditions (Beghi et al., Epilepsia 2010). ASS are a particularly frequent phenomenon in neurological and neurosurgical intensive care medicine. According to a significant study published in 2009 (Hesdorffer et al., Epilepsia), the cumulative 10-years risk of unprovoked seizure relapse after an acute symptomatic seizure is 19% (12-months risk: 13%). Following this finding, current clinical guidelines recommend to treat acute symptomatic seizures with antiseizure drugs for a short time only (during the "acute phase") or not at all (see AWMF S1 guideline on first epileptic seizures and epilepsy in adults, 2017, or ESO guideline, European Stroke Journal 2017). However, evidence for this recommendation is low as it is mainly based on the study mentioned above. Patients included in that study had their index seizures between 1955 and 1984, and it remains unclear as to whether and at what time they were treated with antiseizure drugs. Clinical experience shows that patients with ASS are frequently treated far longer than clinically necessary (Vorderwülbecke et al., J Neurol 2018). The PROSE register aims at following up on patients with ASS but without long-term antiseizure medication. The expected results of the study shall demonstrate that (or: in which cases) antiseizure drugs can be discontinued safely before a patient is discharged from the intensive care unit, without a relevant risk of unprovoked seizure relapse. Most ASS result from a structural cause (Beleza, Neurologist 2012), and the risk of seizure relapse in patients with ASS due to structural brain lesions is of special interest for many neurologists. Therefore, the PROSE register especially focuses on the subgroup of ASS with structural aetiology. Participants will be followed up for at least 12 months to verify or falsify the following primary hypothesis: After an acute symptomatic first epileptic seizure of structural aetiology (e.g, cerebrovascular, traumatic), the 12-months risk for unprovoked seizure relapse is not higher than 25%, even if patients were not treated with antiseizure drugs or treated for a short period only. The secondary hypothesis reads: Acute symptomatic first seizures due to structural CNS lesions have a higher risk for unprovoked seizure relapse than acute symptomatic first seizures due to another aetiology (e.g., metabolic). This study is coordinated by the research group on Clinical and Experimental Epileptology at Charité - Universitätsmedizin Berlin and is conducted as a multicentre study within the IGNITE! study network (Initiative of German Neuro-Intensive Trial Engagement).
Health condition or problem studied
- ICD10:
- G40.5 - Special epileptic syndromes
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- After an acute symptomatic first seizure, participants will be followed up for 12 months and interviewed regarding seizure relapse, seizure related hospitalisation, antiepileptic medication, and overall functional outcome.
Endpoints
- Primary outcome:
- Occurrence and time point of a first unprovoked epileptic seizure relapse within 12 months after the acute symptomatic first seizure.
- Secondary outcome:
- Occurrence and time point of additional acute symptomatic seizures; initiation of an antiepileptic medication; seizure related rehospitalisation; overall functional outcome (Modified Rankin Score).
Study Design
- Purpose:
- Prognosis
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum des Saarlandes Homburg / Saar
- University medical center Universitätsklinikum Leipzig Leipzig
- Medical center Klinikum Osnabrück Osnabrück
- University medical center Universitätsmedizin Rostock Rostock
- University medical center Charité - Universitätsmedizin Berlin Berlin
- University medical center Universitätsklinikum Jena Jena
- University medical center Universitätsklinikum Heidelberg Heidelberg
- University medical center Universitätsklinikum Freiburg Freiburg im Breisgau
- University medical center Universitätsmedizin Mannheim Mannheim
- University medical center Universitätsklinikum Köln Köln
Recruitment period and number of participants
- Planned study start date:
- 2019-08-15
- Actual study start date:
- 2019-09-18
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 115
- Final Sample Size:
- 133
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Acute symptomatic first epileptic seizure
Exclusion Criteria
Status epilepticus
Addresses
Primary Sponsor
- Address:
- Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Epilepsie-Zentrum Berlin-BrandenburgCharitéplatz 110117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité - Universitätsmedizin Berlin, Klinik für NeurologiePD Dr. med. Bernd VorderwülbeckeCharitéplatz 110117 BerlinGermany
- Telephone:
- +4930450560560
- Fax:
- +4930450560938
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Charité - Universitätsmedizin Berlin, Klinik für NeurologieDr. med. Julia Herzig-NichtweißCharitéplatz 110117 BerlinGermany
- Telephone:
- +4930450660057
- Fax:
- +4930450560962
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Charité - Universitätsmedizin Berlin, Klinik für NeurologiePD Dr. med. Bernd VorderwülbeckeCharitéplatz 110117 BerlinGermany
- Telephone:
- +4930450560560
- Fax:
- +4930450560938
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Charité Campus Charité MitteCharitéplatz 110117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-07-02
- Ethics committee number:
- EA2/016/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-07-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- After completion of the study, study protocol and anonymised individual participant data will be shared upon reasonable request.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Herzig-Nichtweiß J et al., Studienprotokoll: Register zur Prognose akut-symptomatischer Anfälle (PROSA-Register) – eine prospektive multizentrische Beobachtungsstudie. Z Epileptol 2021;34:349–54.
- Herzig-Nichtweiß J et al., Prognosis and management of acute symptomatic seizures: a prospective, multicenter, observational study. Ann Intensive Care 2023 Sep 15;13(1):85.
- Date of first publication of study results:
- 2023-09-15
- DRKS entry published for the first time with results:
- 2023-09-25
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry