Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures

Inflammation Clinical Trial

— ADhipfract  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409082
• Other study ID #: HOFTDEM
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: April 25, 2017
• Start date: September 11, 2013
• Est. completion date: December 20, 2016

Study information

• Verified date: April 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 20, 2016
• Est. primary completion date: June 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hip fracture with a planed spinal anesthesia

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimers Disease
• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Inflammation

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Molndal	Vastra Gotaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality and morbidity	interview by phone and death registration	1year