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Clinical Trials/NCT00202475
NCT00202475CompletedPhase 3

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

Sanquin Research & Blood Bank Divisions4 sites in 1 country100 target enrollmentStarted: September 1, 2003Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
100
Locations
4
Primary Endpoint
decline in Hemoglobine levels

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Elective surgery

Exclusion Criteria

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

Outcomes

Primary Outcomes

decline in Hemoglobine levels

Time Frame: surgery

Secondary Outcomes

  • Storage parameters- ATP(35 days)

Investigators

Sponsor
Sanquin Research & Blood Bank Divisions
Sponsor Class
Other

Study Sites (4)

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