Collection of Autologous Blood Products by Double Erythrocytapheresis

This study has been completed.
Sponsor:
Collaborators:
Atrium Medical Center
Maasland Hospital
Information provided by:
Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:
NCT00202475
First received: September 13, 2005
Last updated: October 19, 2009
Last verified: October 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Active Comparator: 1 Procedure: eythrocytapheresis
machinal collection of erythrocytes
Other Name: apheresis
Active Comparator: 2 Procedure: whole blood collection
collection of whole blood
Other Name: blood donation

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 Bloodbank
Maastricht, Limburg, Netherlands, 6229 GS
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:
No publications provided

Responsible Party: Dr. Wim de Kort PhD, Sanquin Blood BankDivision South-east
ClinicalTrials.gov Identifier: NCT00202475     History of Changes
Other Study ID Numbers: PPO-C-02-15
Study First Received: September 13, 2005
Last Updated: October 19, 2009
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 April 16, 2014