Incidence and Reasons for Preoperative Anemia in Elective... | NCT02385409

Studies
Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty

NCT02385409

Sponsor

Oeivind Jans

Status

Unknown status

Last Update Posted

Mar 11, 2015Estimated

Enrollment

900Estimated

Phase

Not provided

Conditions

Anemia
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee

Interventions

Not provided

Countries

Denmark

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

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

May 2014Actual

Completion Date

May 2015Estimated

First Submitted Date

Feb 16, 2015

First Submission Date that Met QC Criteria

Mar 5, 2015

First Posted Date

Mar 11, 2015Estimated

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

Mar 5, 2015

Last Update Posted Date

Mar 11, 2015Estimated

Name	Class
Hvidovre University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.

Treatment of preoperative anemia is recommended. However the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied.

This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

Detailed Description

Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.

In elective orthopedic surgery, international guidelines recommends treatment of preoperative anemia including the use of Iron supplements for anemias associated with iron deficiency. In addition, low iron stores in both anemic and non-anemic patients may delay postoperative hemoglobin recovery.

However, the reasons for preoperative anemia and the prevalence of patients with low iron stores have only been sparsely studied in elective hip- and knee arthroplasty.

This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

900Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elective Total Hip- or Knee arthroplasty patients		Patients scheduled for elective Hip- or knee replacement at Hvidovre Hospital, Denmark.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anemia Classification - Biochemical classification from preoperative venous blood samples	Biochemical classification from preoperative venous blood samples	Date of preoperative blood sampling

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of Anemia according to WHO definitions	According to WHO definitions	Date of preoperative blood sampling
Proportions of non-anemic patients with low irons stores	Low Ferritin or Transferin saturation (TSAT)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Scheduled for elective primary hip- or knee replacement.

Exclusion Criteria:

Not possible to obtain preoperative blood sample.

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

All patients scheduled for elective primary hip- and knee replacement during a 1 year sampling period at the department of orthopedic surgery, Hvidovre Hospital, Denmark

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Øivind Jans, M.D., Ph.D.	Rigshospitalet, Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital, Department of orthopaedic surgery		Hvidovre		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

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Browse Branches

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