Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
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.
|Coxarthrosis||Procedure: Autologous blood transfusion Procedure: Allogeneic blood transfusion|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients|
- 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.
|Study Start Date:||December 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Allogeneic blood
Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.
Procedure: Allogeneic blood transfusion
Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.
Experimental: Autologous blood
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.
Procedure: Autologous blood transfusion
Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725724
|Haukeland University Hospital|
|Kysthospitalet i Hagevik|
|Principal Investigator:||Tor A Hervig, MD, PhD||Haukealnd University Hospital|