Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures (ADhipfract)

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Hip Fracture; Alzheimers Disease

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Sweden
  • Vastra Gotaland
    • Molndal, Vastra Gotaland, Sweden, 431 80
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with an acute hip fracture receiving a spinal anesthesia

Description

Inclusion Criteria:

• Hip fracture with a planed spinal anesthesia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality and morbidity	interview by phone and death registration	1year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2013
• Primary Completion (Actual): June 22, 2015
• Study Completion (Actual): December 20, 2016

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Leg Injuries; Neurodegenerative Diseases; Dementia; Tauopathies; Femoral Fractures; Hip Injuries; Inflammation; Alzheimer Disease; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: HOFTDEM