Clinical trial NCT01725724: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coxarthrosis
Keywords: Autologous blood transfusion
Allogeneic blood transfusion
Infection rate
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2012-11-14
Enrollment: 162
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Body temperature
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
measure: C-reactive protein (CRP)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
measure: White blood cells (WBC)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Hagavik
country: Norway
facility: Kysthospitalet i Hagevik
city: Kristiansand
country: Norway
facility: Soerlandet hospital
city: Stord
country: Norway
facility: Stord Hospital
Study officials:
affiliation: Haukealnd University Hospital
name: Tor A Hervig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: