Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic blood | Active Comparator | Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous blood transfusion | Procedure | Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body temperature | The body temperature is measured as a part of infection monitoring. | 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. | 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. | Participants will be followed for the duration of hospital stay, an expected average of 8 days. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tor A Hervig, MD, PhD | Haukealnd University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Norway | ||||
| Kysthospitalet i Hagevik |
Not provided
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001804 | Blood Transfusion, Autologous |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Allogeneic blood transfusion | Procedure | Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals. |
|
| Hagavik |
| Norway |
| Soerlandet hospital | Kristiansand | Norway |
| Stord Hospital | Stord | Norway |
| D012216 |
| Rheumatic Diseases |