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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coxarthrosis

Intervention / Treatment
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* Procedure: Autologous blood transfusion
* Procedure: Allogeneic blood transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allogeneic blood<br>Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions. | Procedure: Allogeneic blood transfusion<br>* Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.<br>|
| Experimental: Autologous blood<br>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<br>* Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous blood transfusion, Allogeneic blood transfusion, Infection rate