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

Haukeland University Hospital

Status: Completed

Conditions: Coxarthrosis

Treatments: Procedure: Autologous blood transfusion; Procedure: Allogeneic blood transfusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01725724

2009/763

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients with a known hemolytic anemia (congenital or acquired)
• Patients for whom informed consent has not been obtained

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

162 participants in 2 patient groups

Allogeneic blood

Active Comparator group

Description:

Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.

Treatment:

Procedure: Allogeneic blood transfusion

Autologous blood

Experimental group

Description:

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.

Treatment:

Procedure: Autologous blood transfusion