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

October 10, 2011
September 12, 2012
October 2011
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01452581 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthroplasty, Hip
  • 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.
  • 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.
  • 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)

    Intervention: Other: Red blood cell transfusion
  • 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.
    Intervention: Drug: Voluven
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01452581
H-4-2011-058
No
Oeivind Jans, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Oeivind Jans, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP