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Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Primary Purpose

Arthroplasty, Hip

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Red blood cell transfusion
Voluven
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty, Hip focused on measuring Transfusion, Red blood cells, Postoperative, Dizziness, Hip Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 and able to give consent
  • Hip arthroplasty or hip revision arthroplasty
  • Haemoglobin > 4.8 mmol/L and < 6.0 mmol/L on the first postoperative day
  • Dizziness score ≥ 2.

Exclusion Criteria:

  • Large ongoing bleeding
  • Has already received RBC during the current admission
  • New onset of cardiac arrhythmia suspected to be related to anemia
  • Severe ischemic heart disease
  • Renal failure with dialyses or oligouria / anuria.

Sites / Locations

  • Gentofte Hospital, Department of orthopedic surgery
  • Vejle Sygehus, Department of orthopedic surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RBC transfusion

Restrictive: Colloid infusion

Arm Description

Administration of up to 2 RBC units on the first postoperative day. (1 unit at a time followed by evaluation of the primary outcome measure)

Infusion of up to 2 x 280 ml colloid (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride). 280 ml at a time. Evaluation of primary outcome after each intervention.

Outcomes

Primary Outcome Measures

Postoperative Dizziness scale
Dizziness scale (0-3) evaluated by the study nurse. The scale is evaluated upon information on the 1) severeness of dizziness AND 2) it´s consequenses for early mobilization after surgery. 0 - No dizziness. - Light dizziness / No consequences for mobilization - Moderate dizziness / Only shorter periods of mobilization possible - Severe dizziness / No or only short bedside mobilization possible

Secondary Outcome Measures

Timed up and go test (TUG)
Measures the time it take the subject to rise from a chair, walk 3 meters and return to the chair.
Fatigue score
Numeric rating scale 0-10, measuring subjective feeling of fatigue.
FACT-Anemia scale
Validated subjective score addressing anemia related symptoms.

Full Information

First Posted
October 10, 2011
Last Updated
March 5, 2015
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01452581
Brief Title
Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
Official Title
Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of transfusion of red blood cells in treating postoperative dizziness in patients with moderate postoperative anemia after total hip arthroplasty.
Detailed Description
Hip arthroplasty is associated with bleeding and postoperative anemia. However, the optimal strategy for transfusing red blood cells (RBC) remains to be elucidated. Postoperative anemia may cause dizziness and fatigue which delays early mobilization after surgery and may trigger the transfusion of one or more RBC units. However, it is not known whether the administration of 1-2 units of RBC to patients suffering from moderate postoperative anemia (HB 7.5 - 10 g/dl) will improve postoperative dizziness. Thus, this randomized controlled study aims to evaluate whether the administration of 1-2 RBC units on the first postoperative day improves postoperative dizziness in patients undergoing total hip arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Hip
Keywords
Transfusion, Red blood cells, Postoperative, Dizziness, Hip Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RBC transfusion
Arm Type
Active Comparator
Arm Description
Administration of up to 2 RBC units on the first postoperative day. (1 unit at a time followed by evaluation of the primary outcome measure)
Arm Title
Restrictive: Colloid infusion
Arm Type
Placebo Comparator
Arm Description
Infusion of up to 2 x 280 ml colloid (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride). 280 ml at a time. Evaluation of primary outcome after each intervention.
Intervention Type
Other
Intervention Name(s)
Red blood cell transfusion
Intervention Description
Maximal 2 units of packed red blood cells given one at a time on the first postoperative day. Evaluation of primary outcome is done after administration of each unit.
Intervention Type
Drug
Intervention Name(s)
Voluven
Intervention Description
Infusion of up to 2 x 280 ml colloid (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride). 280 ml at a time. Evaluation of primary outcome after each intervention.
Primary Outcome Measure Information:
Title
Postoperative Dizziness scale
Description
Dizziness scale (0-3) evaluated by the study nurse. The scale is evaluated upon information on the 1) severeness of dizziness AND 2) it´s consequenses for early mobilization after surgery. 0 - No dizziness. - Light dizziness / No consequences for mobilization - Moderate dizziness / Only shorter periods of mobilization possible - Severe dizziness / No or only short bedside mobilization possible
Time Frame
Day 1 after surgery
Secondary Outcome Measure Information:
Title
Timed up and go test (TUG)
Description
Measures the time it take the subject to rise from a chair, walk 3 meters and return to the chair.
Time Frame
Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
Title
Fatigue score
Description
Numeric rating scale 0-10, measuring subjective feeling of fatigue.
Time Frame
Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
Title
FACT-Anemia scale
Description
Validated subjective score addressing anemia related symptoms.
Time Frame
7 and 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 and able to give consent Hip arthroplasty or hip revision arthroplasty Haemoglobin > 4.8 mmol/L and < 6.0 mmol/L on the first postoperative day Dizziness score ≥ 2. Exclusion Criteria: Large ongoing bleeding Has already received RBC during the current admission New onset of cardiac arrhythmia suspected to be related to anemia Severe ischemic heart disease Renal failure with dialyses or oligouria / anuria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oeivind Jans, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital, Department of orthopedic surgery
City
Gentofte
Country
Denmark
Facility Name
Vejle Sygehus, Department of orthopedic surgery
City
Vejle
Country
Denmark

12. IPD Sharing Statement

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Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

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