Blood TransfusionNCT00950547
ICU Cell Saver to Reduce Blood Transfusions in Cardiac
A study testing CARDIOPAT and Traditional Chest Drains in people with Blood Transfusion and Cardiac Surgery, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic blood requirements. Limitations of previous trials include the use of cell saver systems in selected high risk patients only or the lack of blood transfusion-sparing strategies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Transfusion, Cardiac Surgery
- What is being tested?
- CARDIOPAT and Traditional Chest Drains
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2009to Jan 2010
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients presenting for cardiac Surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routinely Use of CardioPAT Cell Saver in Cardiac Surgery: A Prospective Randomized Study Focused on Allogenic Blood Transfusion and Clinical Outcome
PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic blood requirements. Limitations of previous trials include the use of cell saver systems in selected high risk patients only or the lack of blood transfusion-sparing strategies. The aim of this prospective randomized study is to evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery.
METHODS: The investigators will randomize 350 patients in two groups: group 1 receives a CardioPAT cell saver device (175 patients), group 2 doesn't receive any cell saver device. The incidence of allogenic blood transfusion and clinical outcome in both groups are evaluated.
- Conditions
- Blood Transfusion, Cardiac Surgery
- Being tested
- CARDIOPAT, Traditional Chest Drains
- Keywords
- Blood Transfusion, Cell Saver, Cardiac Surgery, Evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery in reducing blood transfusions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDIOPATDevice
Cell Saver System at bedside for ICU stay
Traditional Chest DrainsDevice
Chest drains as usual with no possibility to reinfuse lost blood
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Traditional Chest drains Receives: Device: Traditional Chest Drains |
| CARDIOPAT | Experimental | CARDIOPAT Cell Saver after Surgery Receives: Device: CARDIOPAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Transfusions per patient
Measured: 10 days after surgery
Secondary outcomes (1)
Mortality
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood TransfusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950547
- Sponsor's protocol ID
- 00-02
- Status last verified
- Jan 2010
- First submitted
- 30 Jul 2009
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routinely Use of CardioPAT Cell Saver in Cardiac Surgery: A Prospective Randomized Study Focused on Allogenic Blood Transfusion and Clinical Outcome
- ClinicalTrials.gov ID
- NCT00950547
- Acronym / sponsor ID
- 00-02
- Conditions
- Blood Transfusion, Cardiac Surgery
- Keywords
- Blood Transfusion, Cell Saver, Cardiac Surgery, Evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery in reducing blood transfusions.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Jul 2009 (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.
PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic blood requirements. Limitations of previous trials include the use of cell saver systems in selected high risk patients only or the lack of blood transfusion-sparing strategies. The aim of this prospective randomized study is to evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery.
METHODS: The investigators will randomize 350 patients in two groups: group 1 receives a CardioPAT cell saver device (175 patients), group 2 doesn't receive any cell saver device. The incidence of allogenic blood transfusion and clinical outcome in both groups are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Traditional Chest DrainsTraditional Chest drains |
| CARDIOPAT | Experimental | Device: CARDIOPATCARDIOPAT Cell Saver after Surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting for cardiac Surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CARDIOPATCell Saver System at bedside for ICU stay | Device | CARDIOPAT |
| Traditional Chest DrainsChest drains as usual with no possibility to reinfuse lost blood | Device | Control |
Primary outcome
Number of Transfusions per patient
Time frame: 10 days after surgery
1 secondary outcome
Mortality
Time frame: 30 days after surgery
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 5 Jan 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARDIOPAT and Traditional Chest Drains in people with Blood Transfusion and Cardiac Surgery, run by Cardiochirurgia E.H. at 1 site in Italy.
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 1 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 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
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?
Number of Transfusions per patient (time frame: 10 days after 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 5 Jan 2010.