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Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

This study has been completed.
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: April 8, 2015
Last verified: April 2015
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

Enrollment: 1012
Study Start Date: January 2011
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280253

Locations
Sweden
Skane University Hospital, Lund
Lund, Skane, Sweden, 22285
Sponsors and Collaborators
Region Skane
Anna and Edwin Berger Foundation
Investigators
Principal Investigator: Peter Bentzer, MD, PhD Skane University Hospital
  More Information

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: April 8, 2015
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 September 23, 2016