NCT02385383

Brief Summary

This observational study follows a cohort of patients scheduled for elective hip- or knee surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to surgery according to a recently introduced standardized treatment protocol at 6 high-volume surgical centres.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

February 16, 2015

Last Update Submit

March 10, 2015

Conditions

AnemiaArthroplasty, Replacement, HipArthroplasty, Replacement, Knee

Keywords

Patient Blood ManagementPreoperative anemiaIV Iron

Outcome Measures

Primary Outcomes (1)

  • Transfusion Rate

    Blood transfusion (yes/no) during the entire hospital stay

    From date of admission to date of discharge (up to 30 days)

Secondary Outcomes (5)

  • Classification of preoperative anemia

    4 weeks prior to surgery (baseline)

  • Change in hemoglobin concentration

    From date of preoperative blood sampling (baseline) to date of admission (Up to 4 weeks)

  • No. of red blood cell units administered per patient

    From date of admission to date of discharge (up to 30 days)

  • Length of Hospital stay

    From date of admission to Date of discharge (up to 30 days)

  • Postoperative complications and readmissions

    From date of surgery up to 90 days after surgery

Study Arms (2)

Patients with preoperative anemia following treatment protocol

Patients with preoperative anemia according to the WHO definition and treated with a protocol of Iitravenous iron prior to surgery

Drug: Iron-III Isomaltoside 1000

Patients with preoperative anemia - Historical control

Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control

Other: Standard Care

Interventions

Iron-III Isomaltoside 1000DRUG

Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000

Also known as: Monofer
Patients with preoperative anemia following treatment protocol
Standard CareOTHER

Standard Care in a historical control cohort

Patients with preoperative anemia - Historical control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective hip or knee arthroplasty presenting with preoperative anemia.

You may qualify if:

  • Age \> 18 years
  • Scheduled for elective primary hip- or knee arthroplasty
  • Preoperative hemoglobin \< 13 g/dl (males) or \< 12 g/dl (females)
  • Included in the departments treatment protocol for preoperative anemia

You may not qualify if:

  • Cronic transfusion need
  • Not able to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Bisbebjerg Hospital, Dept. of orthopedic surgery

Copenhagen NV, 2400, Denmark

RECRUITING

Farsø Sygehus

Farsø, 9640, Denmark

RECRUITING

Gentofte Hospital, Dept. of orthopedic surgery

Hellerup, 2900, Denmark

RECRUITING

Hvidovre Hospital, Department of orthopaedic surgery

Hvidovre, 2650, Denmark

RECRUITING

Vejle Sygehus, Dept. of orthopedic surgery

Vejle, 7100, Denmark

RECRUITING

Viborg Sygehus, Dept. of orthopedic surgery

Viborg, 8800, Denmark

RECRUITING

MeSH Terms

Conditions

Anemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Oeivind Jans, M.D., Ph.D.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oeivind Jans, M.D., Ph.D.

CONTACT

+4521688012oeivind.jans@rh.regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 11, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

February 1, 2017

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

DK(6)