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

This study has been completed.
Sponsor:
Collaborator:
Dentsply Implants
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01725724
First received: April 17, 2012
Last updated: August 28, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Implants
Investigators
Principal Investigator: Tor A Hervig, MD, PhD Haukealnd University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01725724     History of Changes
Other Study ID Numbers: 2009/763
Study First Received: April 17, 2012
Last Updated: August 28, 2013
Health Authority: Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on July 29, 2014