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Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

This study is currently recruiting participants.
Verified September 2012 by Region Skane
Sponsor:
Collaborator:
Anna and Edwin Berger foundation
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01280253
First received: January 18, 2011
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Hip Fracture

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    Infectious complications Cardiovascular complications Throboembolic complications Respiratory complications Renal complications Surgical complications


Biospecimen Retention:   Samples Without DNA

Litium-heparin plasma EDTA plasma


Estimated Enrollment: 1000
Study Start Date: January 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients presenting with hip fracture at University Hospital Lund Sweden

Criteria

Inclusion Criteria:

  • Patients presenting with hip fracture at University Hospital Lund Sweden
  • Informed consent

Exclusion Criteria:

  • No consent can be obtained
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280253

Contacts
Contact: Peter Bentzer, MD, PhD peter.bentzer@hotmail.com

Locations
Sweden
Skane University Hospital, Lund Recruiting
Lund, Skane, Sweden, 22285
Contact: Peter Bentzer, MD, PhD         peter.bentzer@hotmail.com    
Principal Investigator: Peter Bentzer, MD,PhD            
Principal Investigator: Ami Hommel, PhD            
Sponsors and Collaborators
Region Skane
Anna and Edwin Berger foundation
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01280253     History of Changes
Other Study ID Numbers: USILAN-2, 2010, 1837
Study First Received: January 18, 2011
Last Updated: September 10, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Predictor
outcome
biochemical

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 21, 2013