Collection of Autologous Blood Products by Double Erythro... | NCT00202475

Studies
Collection of Autologous Blood Products by Double Erythrocytapheresis

NCT00202475

Sponsor

Sanquin Research & Blood Bank Divisions

Status

Completed

Last Update Posted

Oct 20, 2009Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Pre Operative Autologous Donation

Interventions

eythrocytapheresis
whole blood collection

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Sep 2006Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2009

Last Update Posted Date

Oct 20, 2009Estimated

Name	Class
Atrium Medical Center	OTHER
Maasland Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Procedure: eythrocytapheresis
2	Active Comparator		Procedure: whole blood collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
eythrocytapheresis	Procedure	machinal collection of erythrocytes	1

Measure	Description	Time Frame
decline in Hemoglobine levels		surgery

Measure	Description	Time Frame
Storage parameters- ATP		35 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Rombout, MD	Sanquin Research and Blood Bank Divisions	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanquin Bloodbank		Maastricht	Limburg	6229 GS	Netherlands
Sanquin Blood Bank Southeast Region

Intervention Browse Module

MeSH Terms

ID	Term
D001781	Blood Component Removal
D000094345	Blood Donation

Ancestor Terms

ID	Term
D013812	Therapeutics
D009927	Tissue and Organ Procurement
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided