Arthroplasty, HipNCT01452581
Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
A study testing Red blood cell transfusion and Voluven in people with Arthroplasty, Hip, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Hip
- What is being tested?
- Red blood cell transfusion and Voluven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Gentofte Hospital, Department of orthopedic surgery
Gentofte Municipality
Vejle Sygehus, Department of orthopedic surgery
Vejle
About this study
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.
Read the 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.
- Conditions
- Arthroplasty, Hip
- Being tested
- Red blood cell transfusion, Voluven
- Keywords
- Transfusion, Red blood cells, Postoperative, Dizziness, Hip Arthroplasty
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionOther
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.
VoluvenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Drug: Voluven |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 after surgery
Secondary outcomes (3)
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.
Measured: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
Fatigue score
Numeric rating scale 0-10, measuring subjective feeling of fatigue.
Measured: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
FACT-Anemia scale
Validated subjective score addressing anemia related symptoms.
Measured: 7 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, HipStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Oeivind Jans, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452581
- Sponsor's protocol ID
- H-4-2011-058
- Status last verified
- Mar 2015
- First submitted
- 10 Oct 2011
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01452581
- Acronym / sponsor ID
- H-4-2011-058
- Conditions
- Arthroplasty, Hip
- Keywords
- Transfusion, Red blood cells, Postoperative, Dizziness, Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBC transfusion | Active comparator | Other: Red blood cell transfusionAdministration of up to 2 RBC units on the first postoperative day. (1 unit at a time followed by evaluation of the primary outcome measure) |
| Restrictive: Colloid infusion | Placebo comparator | Drug: VoluvenInfusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusionMaximal 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. | Other | RBC transfusion |
| VoluvenInfusion 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 | Restrictive: Colloid infusion |
Primary outcome
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
3 secondary outcomes
Timed up and go test (TUG)
Time frame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
Fatigue score
Time frame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
FACT-Anemia scale
Time frame: 7 and 14 days
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oeivind Jans, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red blood cell transfusion and Voluven in people with Arthroplasty, Hip, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Dizziness scale (time frame: Day 1 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.