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Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture
This study has been completed.
Sponsor:
Region Skane
Collaborator:
Anna and Edwin Berger Foundation
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01280253
First received: January 18, 2011
Last updated: November 11, 2016
Last verified: November 2016
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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:
Further study details as provided by Region Skane:
Primary Outcome Measures:
- Mortality [ Time Frame: 30 days ]
Secondary Outcome Measures:
- Morbidity [ Time Frame: 30 day ]Infectious complications Cardiovascular complications Thromboembolic complications Respiratory complications Renal complications Surgical complications
Biospecimen Retention: Samples Without DNA
Litium-heparin plasma EDTA plasma
| Enrollment: | 999 |
| 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) |
| Sexes Eligible for Study: | All |
| 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 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01280253
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 ( Other Grant/Funding Number: Anna och Edwin Berger Foundation ) 1837 ( Other Grant/Funding Number: Region Skane ALF ) |
| Study First Received: | January 18, 2011 |
| Last Updated: | November 11, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Upon reasonable request |
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 19, 2017