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Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01452581
Recruitment Status : Terminated (Lack of enrollment)
First Posted : October 17, 2011
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Arthroplasty, Hip Other: Red blood cell transfusion Drug: Voluven

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
Study Start Date : October 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: RBC transfusion

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)

Other: Red blood cell transfusion
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.
Placebo Comparator: Restrictive: Colloid infusion
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.
Drug: Voluven
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.


Outcome Measures

Primary Outcome Measures :
  1. Postoperative Dizziness scale [ Time Frame: Day 1 after surgery ]

    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.

    1. - Light dizziness / No consequences for mobilization
    2. - Moderate dizziness / Only shorter periods of mobilization possible
    3. - Severe dizziness / No or only short bedside mobilization possible


Secondary Outcome Measures :
  1. Timed up and go test (TUG) [ Time Frame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery) ]
    Measures the time it take the subject to rise from a chair, walk 3 meters and return to the chair.

  2. Fatigue score [ Time Frame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery) ]
    Numeric rating scale 0-10, measuring subjective feeling of fatigue.

  3. FACT-Anemia scale [ Time Frame: 7 and 14 days ]
    Validated subjective score addressing anemia related symptoms.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452581


Locations
Denmark
Gentofte Hospital, Department of orthopedic surgery
Gentofte, Denmark
Vejle Sygehus, Department of orthopedic surgery
Vejle, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Oeivind Jans, MD Rigshospitalet, Denmark
More Information

Responsible Party: Oeivind Jans, M.D, Clinical Assitant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01452581     History of Changes
Other Study ID Numbers: H-4-2011-058
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Oeivind Jans, Rigshospitalet, Denmark:
Transfusion
Red blood cells
Postoperative
Dizziness
Hip Arthroplasty