NCT00202475

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Typical duration for phase_3

Geographic Reach
1 country

2 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

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 20, 2009

Status Verified

October 1, 2009

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

October 19, 2009

Conditions

Pre Operative Autologous Donation

Keywords

Dubble eerythrocytapheresis

Outcome Measures

Primary Outcomes (1)

  • decline in Hemoglobine levels

    surgery

Secondary Outcomes (1)

  • Storage parameters- ATP

    35 days

Study Arms (2)

1

ACTIVE COMPARATOR
Procedure: eythrocytapheresis

2

ACTIVE COMPARATOR
Procedure: whole blood collection

Interventions

eythrocytapheresisPROCEDURE

machinal collection of erythrocytes

Also known as: apheresis
1
whole blood collectionPROCEDURE

collection of whole blood

Also known as: blood donation
2

Eligibility Criteria

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

You may qualify if:

  • Elective surgery

You may not qualify if:

  • Malignancies
  • Severe arrhythmias
  • Congestive heart failure
  • Recent angina
  • Epileptic seizures in the last 3 months before collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanquin Bloodbank

Maastricht, Limburg, 6229 GS, Netherlands

Location

Sanquin Blood Bank Southeast Region

Maastricht, 6229 GR, Netherlands

Location

MeSH Terms

Interventions

Blood Component RemovalBlood Donation

Intervention Hierarchy (Ancestors)

TherapeuticsTissue and Organ ProcurementHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eva Rombout, MD

    Sanquin Research and Blood Bank Divisions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

September 1, 2003

Primary Completion

September 1, 2006

Study Completion

December 1, 2007

Last Updated

October 20, 2009

Record last verified: 2009-10

Locations

NL(2)