CoxarthrosisNCT01725724
Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
A study testing Autologous blood transfusion and Allogeneic blood transfusion in people with Coxarthrosis, run by Haukeland University Hospital at 4 sites in Norway.
Trial summary
The purpose of this study is to compare the infection rate in patients receiving/not receiving their own blood, collected during surgery, during and after orthopedic surgery. The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative infection. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Autologous blood transfusion and Allogeneic blood transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 4 sitesNorway
- Study dates
- Dec 2009to Dec 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a risk of needing red cell transfusion after surgery estimated to be above 75%, judged by preoperative hemoglobin concentration and known risk of preoperative bleeding
- Patients over 16 years of age
- Patients who have consented to participate
Who cannot join
- Patients with a known hemolytic anemia (congenital or acquired)
- Patients for whom informed consent has not been obtained
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland University Hospital
Bergen
Kysthospitalet i Hagevik
Hagavik
Soerlandet hospital
Kristiansand
Stord Hospital
Stord
About this study
The purpose of this study is to compare the infection rate in patients receiving/not receiving their own blood, collected during surgery, during and after orthopedic surgery.
The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative infection.
Read the detailed description
Postoperative infections (both systemic and wound infections) are complications that should be avoided both due to the discomfort and the risk to the patients and for the corresponding increment of hospital costs.
There are some studies indicating that transfusion of autologous salvaged blood may reduce postoperative infections. This may be due to immunostimulating cytokines released in these products. However, as these cytokines also may cause adverse events as febrile transfusion reactions and activation of the complement and the coagulation cascades, the overall impact may be different.
There are two publications from an Austrian group indicating that allogeneic blood transfusion in orthopedic patients cause increased postoperative infection rate irrespectively of the leukocyte content of the red cell concentrates.
The Austrian studies were not randomized. Therefore, it would be useful to perform a randomized, prospective study where the patients receive transfusion of salvaged blood versus allogeneic red cell concentrate as their primary replacement product, respectively.
The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood reduces the infection rate in orthopedic patients compared with patients receiving allogeneic blood transfusion. The study is limited to one source of autologous blood; blood collected by the Sangvia Blood Collection System, and the study is partially sponsored by the manufacturer.
- Conditions
- Coxarthrosis
- Being tested
- Autologous blood transfusion, Allogeneic blood transfusion
- Keywords
- Autologous blood transfusion, Allogeneic blood transfusion, Infection rate
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood transfusionProcedure or surgery
Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
Allogeneic blood transfusionProcedure or surgery
Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic blood | Active comparator | Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions. Receives: Procedure: Allogeneic blood transfusion |
| Autologous blood | Experimental | Autologous blood transfusion. Patients in this arm will receive per- and postoperatively collected autologous blood collected with the Sangvia Blood Collection System. If teh amount of autologous blood is too small for the clinical need, additional allogeneic blood will be transfused. Receives: Procedure: Autologous blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
The body temperature is measured as a part of infection monitoring.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
C-reactive protein (CRP)
CRP i measured as a part of infection monitoring. Because elevated CRP is expected after surgery it is necessary to measure other parameters to in order to monitor infection.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
White blood cells (WBC)
WBC is measured and is a part of the infection monitoring.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Sponsor
- Investigators
- Tor A Hervig, MD, PhD, Principal investigator, Haukealnd University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725724
- Sponsor's protocol ID
- 2009/763
- Status last verified
- Aug 2013
- First submitted
- 17 Apr 2012
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
- ClinicalTrials.gov ID
- NCT01725724
- Acronym / sponsor ID
- 2009/763
- Conditions
- Coxarthrosis
- Keywords
- Autologous blood transfusion, Allogeneic blood transfusion, Infection rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Nov 2012 (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 compare the infection rate in patients receiving/not receiving their own blood, collected during surgery, during and after orthopedic surgery.
The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative infection.
Detailed description
Postoperative infections (both systemic and wound infections) are complications that should be avoided both due to the discomfort and the risk to the patients and for the corresponding increment of hospital costs.
There are some studies indicating that transfusion of autologous salvaged blood may reduce postoperative infections. This may be due to immunostimulating cytokines released in these products. However, as these cytokines also may cause adverse events as febrile transfusion reactions and activation of the complement and the coagulation cascades, the overall impact may be different.
There are two publications from an Austrian group indicating that allogeneic blood transfusion in orthopedic patients cause increased postoperative infection rate irrespectively of the leukocyte content of the red cell concentrates.
The Austrian studies were not randomized. Therefore, it would be useful to perform a randomized, prospective study where the patients receive transfusion of salvaged blood versus allogeneic red cell concentrate as their primary replacement product, respectively.
The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood reduces the infection rate in orthopedic patients compared with patients receiving allogeneic blood transfusion. The study is limited to one source of autologous blood; blood collected by the Sangvia Blood Collection System, and the study is partially sponsored by the manufacturer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic blood | Active comparator | Procedure: Allogeneic blood transfusionAllogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions. |
| Autologous blood | Experimental | Procedure: Autologous blood transfusionAutologous blood transfusion. Patients in this arm will receive per- and postoperatively collected autologous blood collected with the Sangvia Blood Collection System. If teh amount of autologous blood is too small for the clinical need, additional allogeneic blood will be transfused. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a risk of needing red cell transfusion after surgery estimated to be above 75%, judged by preoperative hemoglobin concentration and known risk of preoperative bleeding
- Patients over 16 years of age
- Patients who have consented to participate
Key exclusion criteria (2 listed)
- Patients with a known hemolytic anemia (congenital or acquired)
- Patients for whom informed consent has not been obtained
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 |
|---|---|---|
| Autologous blood transfusionPer- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System. | Procedure or surgery | Autologous blood |
| Allogeneic blood transfusionTransfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals. | Procedure or surgery | Allogeneic blood |
Primary outcome
Body temperature
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
The body temperature is measured as a part of infection monitoring.
C-reactive protein (CRP)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
CRP i measured as a part of infection monitoring. Because elevated CRP is expected after surgery it is necessary to measure other parameters to in order to monitor infection.
White blood cells (WBC)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
WBC is measured and is a part of the infection monitoring.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Tor A Hervig, MD, PhD principal investigator
Haukealnd University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous blood transfusion and Allogeneic blood transfusion in people with Coxarthrosis, run by Haukeland University Hospital at 4 sites in Norway.
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 2 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 30 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 4 sites in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body temperature (time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.). The study lists 3 primary outcomes in all. 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 30 Mar 2015.