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A Clinical Study to Investigate if Transfusion of Patients Own Shed Blood Improves the Immunological Status in Comparison to Transfusion of Donor Blood ("Bank Blood")

NCT ID: NCT00839241

Last Updated: 2021-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

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The primary objective of the study is to compare the immunological status after either autologous blood transfusion as administered by Bellovac® ABT or allogenic blood transfusion, with regards to change in Natural Killer (NK) cell frequency in patients undergoing total knee replacement.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee Blood Transfusion, Autologous Blood Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Blood Transfusion

Group Type EXPERIMENTAL

Bellovac ABT

Intervention Type DEVICE

Bellovac ABT (autologous blood)

Allogenic Blood Transfusion

Group Type ACTIVE_COMPARATOR

Allogenic Blood Transfusion

Intervention Type PROCEDURE

Transfusion of allogenic ("bank") blood.

Interventions

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Bellovac ABT

Bellovac ABT (autologous blood)

Intervention Type DEVICE

Allogenic Blood Transfusion

Transfusion of allogenic ("bank") blood.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* Male and female patients aged 18 years and over scheduled for total knee replacement
* Subjects 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)
* Pre-operatively haemoglobin below normal range as judged by the investigator
* Previous enrolment or randomisation to treatment in the present study
* Expected or confirmed participation in another clinical study during the study period
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
* Current symptoms of haemophilia
* 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) as deemed by investigator
* Use of pre-donation
* Use of recombinant erythropoetin
* Use of other autologous blood transfusion than that with Bellovac ABT, e.g. washed and centrifuged blood like CellSaver
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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Magnus Jacobsson, MD, PhD, Prof.

Role: STUDY_DIRECTOR

Dentsply Sirona Implants and Consumables

Locations

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Specjalistyczny Szpital Im. Alfreda Sokolowskiego

Szczecin, , Poland

Site Status

Countries

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Poland

Other Identifiers

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YA-ABT-0004

Identifier Type: -

Identifier Source: org_study_id