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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
April 17, 2012
November 14, 2012
March 30, 2015
December 2009
December 2012   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01725724 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Coxarthrosis
  • Procedure: Autologous blood transfusion
    Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
  • Procedure: Allogeneic blood transfusion
    Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.
  • Active Comparator: Allogeneic blood
    Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.
    Intervention: Procedure: Allogeneic blood transfusion
  • 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.
    Intervention: Procedure: Autologous blood transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01725724
2009/763
No
Not Provided
Not Provided
Haukeland University Hospital
Haukeland University Hospital
Dentsply Sirona Implants
Principal Investigator: Tor A Hervig, MD, PhD Haukealnd University Hospital
Haukeland University Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP