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Completed

NCT Number: NCT01725724

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous blood transfusion

Procedure

Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.

Allogeneic blood transfusion

Procedure

Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 14, 2012
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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