NCT00822588

Brief Summary

The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who receive their own blood back with the medical device Sangvia. A comparison in need for bank blood will be made between patients that either receive their own blood back or not.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
4 countries

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 3, 2011

Completed
Last Updated

October 4, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

January 13, 2009

Results QC Date

February 18, 2011

Last Update Submit

September 27, 2012

Conditions

Arthroplasty, Replacement, HipBlood TransfusionBlood Transfusion, Autologous

Outcome Measures

Primary Outcomes (1)

  • Number of Participants in Need for Bank Blood Transfusion

    Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared. The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)

    At discharge

Study Arms (2)

1

EXPERIMENTAL
Device: Sangvia® System

2

NO INTERVENTION

Interventions

Sangvia® SystemDEVICE

Sangvia® Intra- and Post-op System

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent
  • Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
  • Classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.

You may not qualify if:

  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
  • Previous enrollment or randomisation of treatment in the present study
  • Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
  • Suspected severe non-compliance to protocol as judged by the investigator
  • Current symptoms of haemophilia
  • Current symptoms of hyperkalaemia
  • Current symptoms of systemic infection or local infection in the operation field
  • Current symptoms of impaired renal function including creatinine/clearance levels above the normal reference values
  • History of or presence of malignant disease with propensity for systemic spread during the last 5 years
  • Current or expected use of cytotoxic drugs
  • Current untreated anaemia (e.g. sickle cell anaemia), i.e. Hb concentration \< 11 g/dl (7 mmol/l)
  • Use of recombinant erythopoetin
  • Use of aprotinin and/or fibrin sealant
  • Use of other autologous blood transfusion than that with the Sangvia® system (e.g. CellSaver, pre-donation, acute normovolemic haemodilution etc.)
  • Women of childbearing age
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical University Vienna, Department of Orthopaedic Surgery

Vienna, 1090, Austria

Location

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, 1091 HA, Netherlands

Location

Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie

Delft, 2600 GA, Netherlands

Location

MC Haaglanden, Orthopedic Dept.

The Hague, 2501 CK, Netherlands

Location

St. Olavs Hospital, Ortopedisk avdelning

Trondheim, 7006, Norway

Location

Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología

Barcelona, 08003, Spain

Location

Related Publications (1)

  • Thomassen BJ, Pilot P, Scholtes VA, Grohs JG, Holen K, Bisbe E, Poolman RW. Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery. PLoS One. 2012;7(9):e44503. doi: 10.1371/journal.pone.0044503. Epub 2012 Sep 13.

    PMID: 23028549DERIVED

Results Point of Contact

Title
Head of Clinical Research Area Health Care
Organization
Astra Tech AB
+46317763000

Study Officials

  • Rudolf Poolman, Dr.

    Onze Lieve Vrouwe Gasthuis (OLVG)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 4, 2012

Results First Posted

May 3, 2011

Record last verified: 2012-09

Locations

AU(1)NO(1)NL(3)ES(1)