NCT01725724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 30, 2015

Status Verified

August 1, 2013

Enrollment Period

3 years

First QC Date

April 17, 2012

Last Update Submit

March 27, 2015

Conditions

Coxarthrosis

Keywords

Autologous blood transfusionAllogeneic blood transfusionInfection rate

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

Allogeneic blood

ACTIVE COMPARATOR

Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.

Procedure: Allogeneic blood transfusion

Autologous blood

EXPERIMENTAL

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.

Procedure: Autologous blood transfusion

Interventions

Autologous blood transfusionPROCEDURE

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

Autologous blood
Allogeneic blood transfusionPROCEDURE

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

Allogeneic blood

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a known hemolytic anemia (congenital or acquired)
  • Patients for whom informed consent has not been obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Haukeland University Hospital

Bergen, Norway

Location

Kysthospitalet i Hagevik

Hagavik, Norway

Location

Soerlandet hospital

Kristiansand, Norway

Location

Stord Hospital

Stord, Norway

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Blood Transfusion, Autologous

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeutics

Study Officials

  • Tor A Hervig, MD, PhD

    Haukealnd University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

November 14, 2012

Study Start

December 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 30, 2015

Record last verified: 2013-08

Locations

NO(4)