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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Coxarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Allogeneic blood

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

Group Type ACTIVE_COMPARATOR

Allogeneic blood transfusion

Intervention Type PROCEDURE

Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.

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.

Group Type EXPERIMENTAL

Autologous blood transfusion

Intervention Type PROCEDURE

Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.

Interventions

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Autologous blood transfusion

Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.

Intervention Type PROCEDURE

Allogeneic blood transfusion

Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.

Intervention Type PROCEDURE

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