Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

NCT01452581 | Terminated

• 1 other identifier: H-4-2011-058
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthroplasty, Hip

Keywords

Transfusion; Red blood cells; Postoperative; Dizziness; Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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. 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

  Day 1 after surgery

Secondary Outcomes (3)

• Timed up and go test (TUG)

  Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)

• Fatigue score

  Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)

• FACT-Anemia scale

  7 and 14 days

Study Arms (2)

RBC transfusion

ACTIVE COMPARATOR

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

Restrictive: Colloid infusion

PLACEBO COMPARATOR

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

Interventions

Red blood cell transfusion OTHER

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.

RBC transfusion

Voluven DRUG

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.

Restrictive: Colloid infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Gentofte Hospital, Department of orthopedic surgery

Gentofte Municipality, Denmark

Location

Vejle Sygehus, Department of orthopedic surgery

Vejle, Denmark

Location

MeSH Terms

Conditions

Dizziness

Interventions

Erythrocyte Transfusion; HES 130-0.4

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Oeivind Jans, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Clinical Assitant

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 17, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

DK (2)