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Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not

NCT ID: NCT00822588

Last Updated: 2012-10-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Hip Blood Transfusion Blood Transfusion, Autologous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Sangvia® System

Intervention Type DEVICE

Sangvia® Intra- and Post-op System

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sangvia® System

Sangvia® Intra- and Post-op System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Fractures
* Revision/secondary total hip surgery with expected serious bone grafting
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wellspect HealthCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rudolf Poolman, Dr.

Role: STUDY_DIRECTOR

Onze Lieve Vrouwe Gasthuis (OLVG)

Locations

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Medical University Vienna, Department of Orthopaedic Surgery

Vienna, , Austria

Site Status

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, , Netherlands

Site Status

Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie

Delft, , Netherlands

Site Status

MC Haaglanden, Orthopedic Dept.

The Hague, , Netherlands

Site Status

St. Olavs Hospital, Ortopedisk avdelning

Trondheim, , Norway

Site Status

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

Barcelona, , Spain

Site Status

Countries

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Austria Netherlands Norway Spain

References

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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.

Reference Type DERIVED
PMID: 23028549 (View on PubMed)

Other Identifiers

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YA-DRA-0001

Identifier Type: -

Identifier Source: org_study_id