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ADhipfract: Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Completed
CT.gov ID
NCT02409082
Collaborator
(none)
400
Enrollment
1
Location
39.3
Actual Duration (Months)
10.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is performed prior to operation. Blood samples and CSF samples are collected at surgery and blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at , 3 months and >1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The hypotheses explored in this investigation is that patients being pre-AD or having AD have worse prognosis following an acute hip fracture. This has been demonstrated in retrospective studies. In this study we admit all patients with a hip fracture planned tro receive a spinal anesthesia. Our golden standard of anesthesia in this patient cohort. Preoperatively Clinical Dementia Score is assessed after study inclosure. At the performance of the spinal dosage is standardized. Prior to giving this 5 ml of CSF is collected and blood is collected. Blood is then collected at intervals up until day 3 postoperatively. We plan to analyze beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at, 3 months and

    1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Presence of Pre-Alzheimers/Alzheimers Disease (AD) and Neuromarkers Related to Morbidity/Mortality in Patients With Acute Hip Fractures
    Actual Study Start Date :
    Sep 11, 2013
    Actual Primary Completion Date :
    Jun 22, 2015
    Actual Study Completion Date :
    Dec 20, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Mortality and morbidity [1year]

      interview by phone and death registration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hip fracture with a planed spinal anesthesia
    Exclusion Criteria:
    • Not receiving a spinal anesthesia i.e. no CSF is available

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University Hospital Molndal Vastra Gotaland Sweden 431 80

    Sponsors and Collaborators

    • Sahlgrenska University Hospital, Sweden

    Investigators

    • Principal Investigator: Bengt M Nellgard, MD PhD, Sahlgrenska University Hospital, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bengt Nellgard, Associate professor/MD/PhD, Sahlgrenska University Hospital, Sweden
    ClinicalTrials.gov Identifier:
    NCT02409082
    Other Study ID Numbers:
    • HOFTDEM
    First Posted:
    Apr 6, 2015
    Last Update Posted:
    Apr 26, 2017
    Last Verified:
    Apr 1, 2017
    Additional relevant MeSH terms:
    Alzheimer Disease
    Inflammation
    Fractures, Bone
    Hip Fractures

    Study Results

    No Results Posted as of Apr 26, 2017