Preoperative Biochemical Predictors of Outcome in Patient... | NCT01280253

Studies
Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

NCT01280253

Sponsor

Region Skane

Status

Completed

Last Update Posted

Nov 15, 2016Estimated

Enrollment

999Actual

Phase

Not provided

Conditions

Hip Fracture

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010	Other Grant/Funding Number	Anna och Edwin Berger Foundation
1837	Other Grant/Funding Number	Region Skane ALF

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Aug 2014Actual

Completion Date

Not provided

First Submitted Date

Jan 18, 2011

First Submission Date that Met QC Criteria

Jan 19, 2011

First Posted Date

Jan 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2016

Last Update Posted Date

Nov 15, 2016Estimated

Name	Class
Anna and Edwin Berger Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

999Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		30 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients presenting with hip fracture at University Hospital Lund Sweden

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Bentzer, MD, PhD	Skane University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skane University Hospital, Lund		Lund	Skåne County	22285	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

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Browse Branches

Not provided