Collection of Autologous Blood Products by Double Erythrocytapheresis

Collection of Autologous Blood Products by Double Erythrocytapheresis - Cost Effectiveness Study

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.

Study Overview

• Status: Completed
• Conditions: Pre Operative Autologous Donation
• Intervention / Treatment: Procedure: eythrocytapheresis; Procedure: whole blood collection

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 GR
    • Sanquin Blood Bank Southeast Region
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 GS
      • Sanquin Bloodbank

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Procedure: whole blood collection; collection of whole blood; Other Names: blood donation
Active Comparator: 1	Procedure: eythrocytapheresis; machinal collection of erythrocytes; Other Names: apheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
decline in Hemoglobine levels	surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Storage parameters- ATP	35 days

Collaborators and Investigators

• Sponsor: Sanquin Research & Blood Bank Divisions
• Collaborators: Atrium Medical Center; Maasland Hospital
• Investigators: Principal Investigator: Eva Rombout, MD, Sanquin Research and Blood Bank Divisions

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): October 20, 2009
• Last Update Submitted That Met QC Criteria: October 19, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Dubble eerythrocytapheresis
• Other Study ID Numbers: PPO-C-02-15