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Clinical Trials/NCT02409082
NCT02409082
Completed
Not Applicable

The Presence of Pre-Alzheimers/Alzheimers Disease (AD) and Neuromarkers Related to Morbidity/Mortality in Patients With Acute Hip Fractures

Sahlgrenska University Hospital, Sweden1 site in 1 country400 target enrollmentSeptember 11, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimers Disease
Sponsor
Sahlgrenska University Hospital, Sweden
Enrollment
400
Locations
1
Primary Endpoint
Mortality and morbidity
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2013
End Date
December 20, 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Bengt Nellgard

Associate professor/MD/PhD

Sahlgrenska University Hospital, Sweden

Eligibility Criteria

Inclusion Criteria

  • Hip fracture with a planed spinal anesthesia

Exclusion Criteria

  • Not receiving a spinal anesthesia i.e. no CSF is available

Outcomes

Primary Outcomes

Mortality and morbidity

Time Frame: 1year

interview by phone and death registration

Study Sites (1)

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