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.

Study Overview

• Status: Completed
• Conditions: Coxarthrosis
• Intervention / Treatment: Procedure: Allogeneic blood transfusion; Procedure: Autologous blood transfusion

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Hagavik, Norway
    • Kysthospitalet i Hagevik
  • Kristiansand, Norway
    • Soerlandet hospital
  • Stord, Norway
    • Stord Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Tor A Hervig, MD, PhD, Haukealnd University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: November 8, 2012
• First Posted (Estimate): November 14, 2012

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Infection rate; Autologous blood transfusion; Allogeneic blood transfusion
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Infections; Osteoarthritis, Hip
• Other Study ID Numbers: 2009/763