Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures

NCT ID: NCT02409082

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-11
• Study Completion Date: 2016-12-20

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.

Conditions

Alzheimers Disease; Inflammation; Hip Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Hip fracture with a planed spinal anesthesia

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bengt Nellgard

Associate professor/MD/PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bengt M Nellgard, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital

Mölndal, Västra Götaland County, Sweden

Countries

Sweden

Other Identifiers

HOFTDEM

Identifier Type: -

Identifier Source: org_study_id