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SPET-72: An Observational Study of Stroke Patients.

Sponsor
Ellen Bøhmer (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03259737
Collaborator
(none)
120
Enrollment
2
Locations
55
Anticipated Duration (Months)
60
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    There is in general a focus on misuse of health resources. An increasing amount of guidelines is produced to reduce the variation in treatment of patients with the same diagnosis. Many recommendations are weak but seems though to have considerable impact on in hospital care. The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent supplementary CT and MRI. The intention is to study these issues in a larger population including an evaluation of utility of the different examinations and evaluations.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.
    Actual Study Start Date :
    May 1, 2018
    Actual Primary Completion Date :
    Nov 15, 2018
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of supplementary computer tomography and magnetic resonance imaging of the brain. [3 months]

      Number

    2. The number of blood sugar measurements [72 hours after admission to hospital]

      Number

    Secondary Outcome Measures

    1. Troponin measurement, [72 hours]

      frequency and level of max value

    2. Number of blood pressure measurement [72 hours]

      Number

    3. Transfer to tertiary center [72 hours]

      Number

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and I64)

    • Hospitalized between January 1 and December 31, 2015

    Exclusion Criteria:

    • Previous hospitalization with a diagnosis of stroke in 2015.

    • Foreigners and patients from other regions of Norway.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Innlandet Hospital Trust Lillehammer Lillehammer Norway 2609
    2 Ellen Bøhmer Lillehammer Norway

    Sponsors and Collaborators

    • Ellen Bøhmer

    Investigators

    • Study Director: Ingebjørg Hartz, Sykehuset Innlandet HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ellen Bøhmer, PHD cand med, Sykehuset Innlandet HF
    ClinicalTrials.gov Identifier:
    NCT03259737
    Other Study ID Numbers:
    • REK2015/358
    First Posted:
    Aug 24, 2017
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cerebrovascular Disorders
    Hyperglycemia

    Study Results

    No Results Posted as of Jan 5, 2021