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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725724
First Posted: November 14, 2012
Last Update Posted: March 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Haukeland University Hospital
  Purpose

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.


Condition Intervention
Coxarthrosis Procedure: Autologous blood transfusion Procedure: Allogeneic blood transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Body temperature [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days. ]
    The body temperature is measured as a part of infection monitoring.

  • C-reactive protein (CRP) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days. ]
    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.

  • White blood cells (WBC) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days. ]
    WBC is measured and is a part of the infection monitoring.


Enrollment: 162
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725724


Locations
Norway
Haukeland University Hospital
Bergen, Norway
Kysthospitalet i Hagevik
Hagavik, Norway
Soerlandet hospital
Kristiansand, Norway
Stord Hospital
Stord, Norway
Sponsors and Collaborators
Haukeland University Hospital
Dentsply Sirona Implants
Investigators
Principal Investigator: Tor A Hervig, MD, PhD Haukealnd University Hospital
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01725724     History of Changes
Other Study ID Numbers: 2009/763
First Submitted: April 17, 2012
First Posted: November 14, 2012
Last Update Posted: March 30, 2015
Last Verified: August 2013

Keywords provided by Haukeland University Hospital:
Autologous blood transfusion
Allogeneic blood transfusion
Infection rate

Additional relevant MeSH terms:
Infection
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases