Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures

Completed

• Conditions: Inflammation; Alzheimers Disease; Hip Fracture

• Registration Number: NCT02409082
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2013-09-11
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-06
• Primary Completion: 2015-06-22
• Study Completion: 2016-12-20
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Hip fracture with a planed spinal anesthesia

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality and morbidity	1year	interview by phone and death registration

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Molndal, Vastra Gotaland, Sweden