Pre Operative Autologous Donation Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | December 2007 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Elective surgery Exclusion Criteria: - Malignancies - Severe arrhythmias - Congestive heart failure - Recent angina - Epileptic seizures in the last 3 months before collection |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Sanquin Blood Bank Southeast Region | Maastricht | |
| Netherlands | Sanquin Bloodbank | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Sanquin Research & Blood Bank Divisions | Atrium Medical Center, Maasland Hospital |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | decline in Hemoglobine levels | surgery | Yes | |
| Secondary | Storage parameters- ATP | 35 days | No |