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

Coxarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725724
• Other study ID #: 2009/763
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: March 27, 2015
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

Procedure:
• Autologous blood transfusion
Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
• Allogeneic blood transfusion
Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Kysthospitalet i Hagevik	Hagavik
Norway	Soerlandet hospital	Kristiansand
Norway	Stord Hospital	Stord

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Dentsply Implants

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body temperature	The body temperature is measured as a part of infection monitoring.	Participants will be followed for the duration of hospital stay, an expected average of 8 days.	No
Primary	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.	Participants will be followed for the duration of hospital stay, an expected average of 8 days.	No
Primary	White blood cells (WBC)	WBC is measured and is a part of the infection monitoring.	Participants will be followed for the duration of hospital stay, an expected average of 8 days.	No