Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

June 3, 2011 updated by: Rigshospitalet, Denmark
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen NV
      • Copenhagen, Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital
    • Østerbro
      • Copenhagen, Østerbro, Denmark, 2100
        • Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Patients undergoing replacement of hip arthroplasty
  • Be legally competent
  • Read and understand Danish

Exclusion Criteria:

  • Present malignant disease
  • Known heart disease with functionality equivalent to NYHA II or CCS II or worse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Allowed drop in hemoglobin to 4.5-5.5 mmol/L
Transfusion with red blood cells to level between 4.5-5.5 mmol/L
Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L
Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)
Experimental: Allowed drop in hemoglobin to 5.6-6.5 mmol/L
Transfusion with red blood cells to level between 5.6-6.5 mmol/L
Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L
Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go-test (TUG)in seconds.
Time Frame: 30 days
Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The postoperative day patients can walk ten meters
Time Frame: 30 days
30 days
Length of stay at hospital
Time Frame: 30 days
30 days
The day the patient is able to perform Timed Up and Go-test
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

TrygFonden, Denmark

Investigators

  • Principal Investigator: Kamilla Nielsen, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 6, 2011

Last Update Submitted That Met QC Criteria

June 3, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2009-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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