Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
Primary Purpose
Coxarthrosis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Autologous blood transfusion
Allogeneic blood transfusion
Sponsored by
About this trial
This is an interventional prevention trial for Coxarthrosis focused on measuring Autologous blood transfusion, Allogeneic blood transfusion, Infection rate
Eligibility 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
Sites / Locations
- Haukeland University Hospital
- Kysthospitalet i Hagevik
- Soerlandet hospital
- Stord Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Allogeneic blood
Autologous blood
Arm Description
Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.
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.
Outcomes
Primary Outcome Measures
Body temperature
The body temperature is measured as a part of infection monitoring.
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.
White blood cells (WBC)
WBC is measured and is a part of the infection monitoring.
Secondary Outcome Measures
Full Information
NCT ID
NCT01725724
First Posted
April 17, 2012
Last Updated
March 27, 2015
Sponsor
Haukeland University Hospital
Collaborators
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT01725724
Brief Title
Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
Official Title
Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Dentsply Sirona Implants and Consumables
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
Autologous blood transfusion, Allogeneic blood transfusion, Infection rate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic blood
Arm Type
Active Comparator
Arm Description
Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.
Arm Title
Autologous blood
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Autologous blood transfusion
Intervention Description
Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
Intervention Type
Procedure
Intervention Name(s)
Allogeneic blood transfusion
Intervention Description
Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.
Primary Outcome Measure Information:
Title
Body temperature
Description
The body temperature is measured as a part of infection monitoring.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Title
C-reactive protein (CRP)
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Title
White blood cells (WBC)
Description
WBC is measured and is a part of the infection monitoring.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor A Hervig, MD, PhD
Organizational Affiliation
Haukealnd University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Kysthospitalet i Hagevik
City
Hagavik
Country
Norway
Facility Name
Soerlandet hospital
City
Kristiansand
Country
Norway
Facility Name
Stord Hospital
City
Stord
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients
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