NCT01280253

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

3.6 years

First QC Date

January 18, 2011

Last Update Submit

November 11, 2016

Conditions

Hip Fracture

Keywords

Predictoroutcomebiochemical

Outcome Measures

Primary Outcomes (1)

  • Mortality

    30 days

Secondary Outcomes (1)

  • Morbidity

    30 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients presenting with hip fracture at University Hospital Lund Sweden

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skane University Hospital, Lund

Lund, Skåne County, 22285, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Litium-heparin plasma EDTA plasma

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Peter Bentzer, MD, PhD

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 20, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Upon reasonable request

Locations

SE(1)