Cardiopulmonary BypassPhase 2NCT00176657
The Use of HEMOBAG to Salvage Blood After Cardiac Surgery
A Phase 2 study testing HEMOBAG Assessment in people with Cardiopulmonary Bypass and Cardiac Diseases, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
The avoidance of blood transfusions benefits the patient. Cardiopulmonary bypass (CPB) is routinely used in complex cardiac surgeries. This device requires circulating blood through an oxygenator and pump while the heart is stopped. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiopulmonary Bypass, Cardiac Diseases
- What is being tested?
- HEMOBAG Assessment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Apr 2007
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 80 years of age, who are mentally capable of giving an informed consent.
- Electively scheduled cardiac or open heart surgery using the cardiopulmonary bypass pump.
Who cannot join
- Failure to provide an informed consent
- History of trans ischemic attacks (TIA) and/or stroke with residual neurological or cognitive dysfunction
- Currently on dialysis (treatment for kidneys with little or no function)
- History of impaired liver function or coagulopathy
- Hemodynamic instability, cardiogenic shock or severe cardiomegaly
- Scheduled combined surgical procedure (i.e. coronary artery bypass graft [CABG] and endarterectomy)
- If patient has received more than two units of blood in the 12 hours preceding randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass
The avoidance of blood transfusions benefits the patient. Cardiopulmonary bypass (CPB) is routinely used in complex cardiac surgeries. This device requires circulating blood through an oxygenator and pump while the heart is stopped. Upon discontinuation of CPB, the volume of blood in the CPB circuit, approximately 1 to 1.5 liters, is currently processed for the red cell components of the blood. Yet, all the other blood components are available in this volume of blood, but are discarded. The Hemobag filters allow for whole blood reinfusion rather than just red cell reinfusion. Thus, the patient's own platelets, for example, are returned to the patient. The product is just being used clinically and we, the investigators at University of Medicine and Dentistry, New Jersey, have been asked to perform a study on our normal practice (red blood cell return as described above) compared to the whole blood return available with the Hemobag™.
Read the detailed description
The HemobagTM is a bag containing a microfilter for separation of autologous whole blood from intravenous solutions to provide a whole blood reinfusion from a cardiopulmonary bypass machine.
Following cardiopulmonary bypass (CPB), blood remaining within the bypass machine circuit is normally processed by a centrifugal separation of fluids from red blood cells (RBCs) and the RBCs are reinfused back into the patient. An FDA approved device, the HemobagTM, provides an alternative by reinfusing whole blood, including RBCs, from the CPB machine circuit. This allows the patient's own whole blood to be returned back to the patient with all components including functioning, non-activated platelets, coagulation factors and plasma. In preliminary human trials, blood measurements were improved in patients whose CPB blood was processed through the HemobagTM.
This study will evaluate 50 patients whose post-CPB blood is processed by normal practice (centrifugal separation of RBCs for reinfusion) or HemobagTM whole blood reinfusion. Outcome measurements will be chest tube drainage for the initial 24 hours following on-pump cardiac surgery, ventilatory requirements, protein levels, transfusion requirements, coagulation profile, A/A gradients, arterial blood gas measures, and CBC blood panels. All of these data are available from the normal clinical care of the patient.
The hypothesis is that the HemobagTM treated patients will have improved physiologic function from the return of whole blood rather than just RBCs following cardiac surgery using CPB.
- Conditions
- Cardiopulmonary Bypass, Cardiac Diseases
- Being tested
- HEMOBAG Assessment
- Keywords
- cardiac surgery, transfusion
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOBAG AssessmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematology value
Days of hospital stay
Secondary outcomes (2)
Patient's morbidity
Complication rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
- Study completionApr 2007
Why it stopped: Inability to attain sufficient numbers of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Global Blood Resources, LLC
- Investigators
- Douglas J Jackson, MD, Principal investigator, UMDNJ Dept. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176657
- Sponsor's protocol ID
- 0120040166
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 1 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00176657
- Acronym / sponsor ID
- 0120040166
- Conditions
- Cardiopulmonary Bypass, Cardiac Diseases
- Keywords
- cardiac surgery, transfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to attain sufficient numbers of subjects
- Enrolment
- 50 participants
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Global Blood Resources, LLC
- Study start
- Sep 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 15 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 avoidance of blood transfusions benefits the patient. Cardiopulmonary bypass (CPB) is routinely used in complex cardiac surgeries. This device requires circulating blood through an oxygenator and pump while the heart is stopped. Upon discontinuation of CPB, the volume of blood in the CPB circuit, approximately 1 to 1.5 liters, is currently processed for the red cell components of the blood. Yet, all the other blood components are available in this volume of blood, but are discarded. The Hemobag filters allow for whole blood reinfusion rather than just red cell reinfusion. Thus, the patient's own platelets, for example, are returned to the patient. The product is just being used clinically and we, the investigators at University of Medicine and Dentistry, New Jersey, have been asked to perform a study on our normal practice (red blood cell return as described above) compared to the whole blood return available with the Hemobag™.
Detailed description
The HemobagTM is a bag containing a microfilter for separation of autologous whole blood from intravenous solutions to provide a whole blood reinfusion from a cardiopulmonary bypass machine.
Following cardiopulmonary bypass (CPB), blood remaining within the bypass machine circuit is normally processed by a centrifugal separation of fluids from red blood cells (RBCs) and the RBCs are reinfused back into the patient. An FDA approved device, the HemobagTM, provides an alternative by reinfusing whole blood, including RBCs, from the CPB machine circuit. This allows the patient's own whole blood to be returned back to the patient with all components including functioning, non-activated platelets, coagulation factors and plasma. In preliminary human trials, blood measurements were improved in patients whose CPB blood was processed through the HemobagTM.
This study will evaluate 50 patients whose post-CPB blood is processed by normal practice (centrifugal separation of RBCs for reinfusion) or HemobagTM whole blood reinfusion. Outcome measurements will be chest tube drainage for the initial 24 hours following on-pump cardiac surgery, ventilatory requirements, protein levels, transfusion requirements, coagulation profile, A/A gradients, arterial blood gas measures, and CBC blood panels. All of these data are available from the normal clinical care of the patient.
The hypothesis is that the HemobagTM treated patients will have improved physiologic function from the return of whole blood rather than just RBCs following cardiac surgery using CPB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females between the ages of 18 and 80 years of age, who are mentally capable of giving an informed consent.
- Electively scheduled cardiac or open heart surgery using the cardiopulmonary bypass pump.
Key exclusion criteria (7 listed)
- Failure to provide an informed consent
- History of trans ischemic attacks (TIA) and/or stroke with residual neurological or cognitive dysfunction
- Currently on dialysis (treatment for kidneys with little or no function)
- History of impaired liver function or coagulopathy
- Hemodynamic instability, cardiogenic shock or severe cardiomegaly
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 |
|---|---|---|
| HEMOBAG Assessment | Drug | – |
Primary outcome
Hematology value
Days of hospital stay
2 secondary outcomes
Patient's morbidity
Complication rate
Results and safety
The study was stopped early (reason given: Inability to attain sufficient numbers of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2007.
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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.
Douglas J Jackson, MD principal investigator
UMDNJ Dept. of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HEMOBAG Assessment in people with Cardiopulmonary Bypass and Cardiac Diseases, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 May 2007. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Inability to attain sufficient numbers of subjects). Results are not available in the source record.
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?
Hematology value. The study lists 2 primary outcomes in all. 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 1 May 2007.