Collection of Autologous Blood Products by Double Erythrocytapheresis - Full Text View

Sponsors and Collaborators:	Sanquin Research & Blood Bank Divisions Atrium Medical Center Maasland Hospital
Information provided by:	Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:	NCT00202475

Purpose

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.

Condition	Intervention	Phase
Pre Operative Autologous Donation	Procedure: eythrocytapheresis Procedure: whole blood collection	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Collection of Autologous Blood Products by Double Erythrocytapheresis - Cost Effectiveness Study

Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:

decline in Hemoglobine levels [ Time Frame: surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Storage parameters- ATP [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	September 2003
Study Completion Date:	December 2007
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Procedure: eythrocytapheresis machinal collection of erythrocytes
2: Active Comparator	Procedure: whole blood collection collection of whole blood

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Elective surgery

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202475

Locations

Netherlands
Sanquin Blood Bank Southeast Region
Maastricht, Netherlands, 6229 GR

Sponsors and Collaborators

Sanquin Research & Blood Bank Divisions

Atrium Medical Center

Maasland Hospital

Investigators

Principal Investigator:

Eva Rombout, MD

Sanquin Research and Blood Bank Divisions

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanquin Blood BankDivision South-east ( Dr. Wim de Kort PhD )
Study ID Numbers:	PPO-C-02-15
Study First Received:	September 13, 2005
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00202475 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin Research & Blood Bank Divisions:

Dubble eerythrocytapheresis

ClinicalTrials.gov processed this record on May 07, 2009