Pre Operative Autologous DonationPhase 3NCT00202475
Collection of Autologous Blood Products by Double Erythrocytapheresis
A Phase 3 study testing eythrocytapheresis and whole blood collection in people with Pre Operative Autologous Donation, run by Sanquin Research & Blood Bank Divisions at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre Operative Autologous Donation
- What is being tested?
- eythrocytapheresis and whole blood collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2003to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
Who cannot join
- Malignancies
- Severe arrhythmias
- Congestive heart failure
- Recent angina
- Epileptic seizures in the last 3 months before collection
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Sanquin Bloodbank
Maastricht, Limburg, 6229 GS
Sanquin Blood Bank Southeast Region
Maastricht, 6229 GR
About this study
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.
Read the 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.
- Conditions
- Pre Operative Autologous Donation
- Being tested
- eythrocytapheresis, whole blood collection
- Keywords
- Dubble eerythrocytapheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eythrocytapheresisProcedure or surgery
Also called apheresis
machinal collection of erythrocytes
whole blood collectionProcedure or surgery
Also called blood donation
collection of whole blood
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: eythrocytapheresis |
| 2 | Active comparator | Not described Receives: Procedure: whole blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
decline in Hemoglobine levels
Measured: surgery
Secondary outcomes (1)
Storage parameters- ATP
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionSep 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre Operative Autologous DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanquin Research & Blood Bank Divisions
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Medical Center, Maasland Hospital
- Investigators
- Eva Rombout, MD, Principal investigator, Sanquin Research and Blood Bank Divisions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202475
- Sponsor's protocol ID
- PPO-C-02-15
- Status last verified
- Oct 2009
- First submitted
- 13 Sep 2005
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Autologous Blood Products by Double Erythrocytapheresis - Cost Effectiveness Study
- ClinicalTrials.gov ID
- NCT00202475
- Acronym / sponsor ID
- PPO-C-02-15
- Conditions
- Pre Operative Autologous Donation
- Keywords
- Dubble eerythrocytapheresis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanquin Research & Blood Bank DivisionsUniversity, hospital or other
- Collaborators
- Atrium Medical Center, Maasland Hospital
- Study start
- Sep 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: eythrocytapheresis |
| 2 | Active comparator | Procedure: whole blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective surgery
Key exclusion criteria (5 listed)
- Malignancies
- Severe arrhythmias
- Congestive heart failure
- Recent angina
- Epileptic seizures in the last 3 months before collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eythrocytapheresisAlso: apheresismachinal collection of erythrocytes | Procedure or surgery | 1 |
| whole blood collectionAlso: blood donationcollection of whole blood | Procedure or surgery | 2 |
Primary outcome
decline in Hemoglobine levels
Time frame: surgery
1 secondary outcome
Storage parameters- ATP
Time frame: 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Rombout, MD principal investigator
Sanquin Research and Blood Bank Divisions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eythrocytapheresis and whole blood collection in people with Pre Operative Autologous Donation, run by Sanquin Research & Blood Bank Divisions at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decline in Hemoglobine levels (time frame: surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.