Arthroplasty, Replacement, HipNCT00822588
Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not
A study testing Sangvia® System in people with Arthroplasty, Replacement, Hip and Blood Transfusion, run by Wellspect HealthCare at 6 sites in 4 countries.
Trial summary
The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who receive their own blood back with the medical device Sangvia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Blood Transfusion, Blood Transfusion, Autologous
- What is being tested?
- Sangvia® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 6 sitesin 4 countries
- Study dates
- May 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provision of informed consent
- Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
- Classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.
Who cannot join
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrollment or randomisation of treatment in the present study
- Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
- Suspected severe non-compliance to protocol as judged by the investigator
- Current symptoms of haemophilia
- Current symptoms of hyperkalaemia
Show all 17Show fewer
- Current symptoms of systemic infection or local infection in the operation field
- Current symptoms of impaired renal function including creatinine/clearance levels above the normal reference values
- History of or presence of malignant disease with propensity for systemic spread during the last 5 years
- Current or expected use of cytotoxic drugs
- Current untreated anaemia (e.g. sickle cell anaemia), i.e. Hb concentration < 11 g/dl (7 mmol/l)
- Use of recombinant erythopoetin
- Use of aprotinin and/or fibrin sealant
- Use of other autologous blood transfusion than that with the Sangvia® system (e.g. CellSaver, pre-donation, acute normovolemic haemodilution etc.)
- Women of childbearing age
- Fractures
- Revision/secondary total hip surgery with expected serious bone grafting
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Netherlands3 sites
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, 1091 HA
Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie
Delft, 2600 GA
MC Haaglanden, Orthopedic Dept.
The Hague, 2501 CK
Austria1 site
Medical University Vienna, Department of Orthopaedic Surgery
Vienna, 1090
Spain1 site
Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología
Barcelona, 08003
About this study
Official title: A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery
The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who receive their own blood back with the medical device Sangvia.
A comparison in need for bank blood will be made between patients that either receive their own blood back or not.
- Being tested
- Sangvia® System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sangvia® SystemDevice
Sangvia® Intra- and Post-op System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Sangvia® System |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Need for Bank Blood Transfusion
Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared.
The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)
Measured: At discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rudolf Poolman, Dr., Study director, Onze Lieve Vrouwe Gasthuis (OLVG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822588
- Sponsor's protocol ID
- YA-DRA-0001
- Status last verified
- Sep 2012
- First submitted
- 13 Jan 2009
- Last updated
- 4 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thomassen BJ, Pilot P, Scholtes VA, Grohs JG, Holen K, Bisbe E, Poolman RW. Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery. PLoS One. 2012;7(9):e44503. doi: 10.1371/journal.pone.0044503. Epub 2012 Sep 13.
PubMed 23028549
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery
- ClinicalTrials.gov ID
- NCT00822588
- Acronym / sponsor ID
- YA-DRA-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Posted 3 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who receive their own blood back with the medical device Sangvia.
A comparison in need for bank blood will be made between patients that either receive their own blood back or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Sangvia® System |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent
- Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
- Classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.
Key exclusion criteria (17 listed)
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrollment or randomisation of treatment in the present study
- Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
- Suspected severe non-compliance to protocol as judged by the investigator
- Current symptoms of haemophilia
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 |
|---|---|---|
| Sangvia® SystemSangvia® Intra- and Post-op System | Device | 1 |
Primary outcome
Number of Participants in Need for Bank Blood Transfusion
Time frame: At discharge
Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared. The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23028549Thomassen BJ, Pilot P, Scholtes VA, Grohs JG, Holen K, Bisbe E, Poolman RW. Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery. PLoS One. 2012;7(9):e44503. doi: 10.1371/journal.pone.0044503. Epub 2012 Sep 13.
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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.
Rudolf Poolman, Dr. study director
Onze Lieve Vrouwe Gasthuis (OLVG)
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sangvia® System in people with Arthroplasty, Replacement, Hip and Blood Transfusion, run by Wellspect HealthCare at 6 sites in 4 countries.
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 3 inclusion and 17 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: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, Austria, Norway, Spain. 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. 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?
Yes. Results are posted in the registry (first posted 3 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants in Need for Bank Blood Transfusion (time frame: At discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822588, which also lists 1 linked publication.
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 4 Oct 2012; AzTrials last refreshed its copy on 6 Nov 2026.