NCT01725724

Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Autologous blood transfusion	Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
PROCEDURE	Allogeneic blood transfusion	Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-11-14
• Last updated: 2015-03-30

Locations

4 sites across 1 country: Norway