Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

November 11, 2016 updated by: Region Skane

Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?

The objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. During the hospital stay medical history, anesthesiological management recorded. In addition, american society of anesthesiology physiological score (ASA), revised cardiac risk index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded " in house", after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be evaluated with logistic regression analysis. Biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Skane
      • Lund, Skane, Sweden, 22285
        • Skåne University Hospital, Lund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients presenting with hip fracture at University Hospital Lund Sweden

Description

Inclusion Criteria:

  • Patients presenting with out of hospital hip fracture at University Hospital Lund Sweden
  • Informed consent
  • Blood sampling within 3 hrs of first contact with healthcare

Exclusion Criteria:

  • No consent can be obtained
  • Non-operative management
  • Followup through the Swedish National Quality for Hip fracture patients not possible
  • High energy trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 30 day
Infectious complications Cardiovascular complications Thromboembolic complications Respiratory complications Renal complications Surgical complications
30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Peter Bentzer, MD, PhD, Skåne University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 11, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • USILAN-2
  • 1837 (Region Skane ALF)
  • 2010 (Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Fracture

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