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Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01452581
First received: October 10, 2011
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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 Intervention
Arthroplasty, Hip
Other: Red blood cell transfusion
Drug: Voluven

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Postoperative Dizziness scale [ Time Frame: Day 1 after surgery ] [ Designated as safety issue: No ]

    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:
  • Timed up and go test (TUG) [ Time Frame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery) ] [ Designated as safety issue: No ]
    Measures the time it take the subject to rise from a chair, walk 3 meters and return to the chair.

  • Fatigue score [ Time Frame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery) ] [ Designated as safety issue: No ]
    Numeric rating scale 0-10, measuring subjective feeling of fatigue.

  • FACT-Anemia scale [ Time Frame: 7 and 14 days ] [ Designated as safety issue: No ]
    Validated subjective score addressing anemia related symptoms.


Enrollment: 5
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 10, 2011
Last Updated: September 12, 2012
Health Authority: Denmark: The scientific ethical commitee for the capital region of Denmark

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

ClinicalTrials.gov processed this record on November 20, 2014