Collection of Autologous Blood Products by Double Erythrocytapheresis

NCT ID: NCT00202475

Last Updated: 2009-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-12-31

Brief Summary

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The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared.

Detailed Description

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The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared.

Conditions

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Pre Operative Autologous Donation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

eythrocytapheresis

Intervention Type PROCEDURE

machinal collection of erythrocytes

2

Group Type ACTIVE_COMPARATOR

whole blood collection

Intervention Type PROCEDURE

collection of whole blood

Interventions

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eythrocytapheresis

machinal collection of erythrocytes

Intervention Type PROCEDURE

whole blood collection

collection of whole blood

Intervention Type PROCEDURE

Other Intervention Names

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apheresis blood donation

Eligibility Criteria

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Inclusion Criteria

* Elective surgery

Exclusion Criteria

* Malignancies
* Severe arrhythmias
* Congestive heart failure
* Recent angina
* Epileptic seizures in the last 3 months before collection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atrium Medical Center

OTHER

Sponsor Role collaborator

Maasland Hospital

OTHER

Sponsor Role collaborator

Sanquin Research & Blood Bank Divisions

OTHER

Sponsor Role lead

Responsible Party

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Sanquin Blood BankDivision South-east

Principal Investigators

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Eva Rombout, MD

Role: PRINCIPAL_INVESTIGATOR

Sanquin Research and Blood Bank Divisions

Locations

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Sanquin Bloodbank

Maastricht, Limburg, Netherlands

Site Status

Sanquin Blood Bank Southeast Region

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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PPO-C-02-15

Identifier Type: -

Identifier Source: org_study_id

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