Cardiopulmonary BypassPhase 3NCT00624611
The Effect of Washing Red Blood Cells on Post Heart Surgery Blood Loss
A Phase 3 study testing Residual pump blood management post aortic cannula removal in people with Cardiopulmonary Bypass, run by University of British Columbia at 1 site in Canada.
Trial summary
When a child undergoes heart surgery, a heart lung machine is used to keep blood flowing while the child's own heart is stopped. After surgery, a significant amount of the child's own blood is left in this machine. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Residual pump blood management post aortic cannula removal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Aug 2010
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 15 and 30 kg undergoing cardiac surgery requiring cardiopulmonary bypass at British Columbia's Children's Hospital.
- All children will be between 2 and 10 years of age.
- Surgery will only involve single atriotomy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Cardiac Surgery Blood Loss: Effect of Washing Residual Cardiopulmonary Bypass Circuit Blood Red Cells Prior to Re-infusion. A Proof of Concept Study
When a child undergoes heart surgery, a heart lung machine is used to keep blood flowing while the child's own heart is stopped. After surgery, a significant amount of the child's own blood is left in this machine. In the case of small children, the relative amount of blood potentially lost to the child in this way is very large.
In older children, and those who have undergone less complicated surgery, this blood can all returned to the child. Giving the child back his or her own blood makes is less likely that the child will need a transfusion of donated blood.
Read more
However, in younger children, or in children who have undergone more complicated surgery, most or all of this blood is thrown away. This is because of worry that returning this blood may cause bleeding, and excessive bleeding is one of the most feared complications of heart surgery.
This project will explore a method whereby the red blood cells left in the heart lung machine can be returned to children without increasing the risk of bleeding. It will also carefully examine the exact causes of higher bleeding risk in children getting their own blood back so that in the future, all children can have their own blood returned at the end of surgery.
Read the detailed description
The primary hypothesis of this study is that in our study population, compared to re-infusion of residual CPB blood, re-infusion of only the red cell component of residual CPB blood, causes a lesser defect in clotting, leading to decreased hemorrhage and less post-operative blood loss.
The secondary objectives of this project are to document the effects on the clotting system of pump blood re-infusion by means of in laboratory testing. This work has not been done and is of crucial importance to future optimization of the use of pump blood. We expect to detect and quantify with significant accuracy any increased bleeding risk with our hemostatic profiling. This information will be invaluable in planning the safe introduction of residual CPB blood re-infusion smaller children and those with increase risk of postoperative blood loss. Furthermore, we will determine whether or not any of the potentially beneficial effects to the clotting system of returning all components of residual CPB blood, such as an increase in functioning platelets, or an increase in clotting factors, are realized. This information will determine the utility of pursuing means by which these non red cell components of residual CPB blood can be safely re-infused.
Induction of anesthesia, arterial and venous vascular catheter placement, heparin administration, cardiopulmonary bypass machine setup and priming, conduct of CPB, ultrafiltration of blood during CPB, post-CPB protamine administration and post-CPB blood ultrafiltration will all be standardized as per current clinical practice.
Residual CPB blood will be processed and re-infused according to group allocation.
Intravascular volume in the form of crystalloid, and blood products will be administered over and above the study residual blood product infusion as required according to protocol.
Subjects will have blood sampled for hemoglobin concentration immediately after induction of anesthesia and again 24 hours following their surgery.
Arterial blood will be sampled from the patient for a hemostatic profile, outlined in the adjacent text box, after separation from CPB and prior to initiation of residual CPB blood product re-infusion. A second sample will be obtained when re-infusion of residual CPB blood product is complete. In addition, a hemostatic profile will be run directly on a sample of the residual CPB blood product.
Subject demographic data, surgical diagnosis and procedures, CPB data, all medication, blood product and intravenous fluid administration, total volume of study fluid administered, blood lost during surgery to sponges and suction and 24 hour mediastinal drainage will be recorded for all subjects. Any cases of incomplete re-infusion of study blood product will be noted as will the reason for the occurrence.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Residual pump blood management post aortic cannula removal
- Keywords
- CPB, red blood cell washing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residual pump blood management post aortic cannula removalProcedure or surgery
Residual pump blood will be maximally hemoconcentrated by further ultrafiltation within the CPB machine. Resulting hematocrit will be approximately 0.4. The total residual pump blood volume, approximately 300ml, will be reinfused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Additional protamine sulfate will be given every 30 minutes during the infusion, .03 mg/ml of residual pump blood. Procedures in this group do not deviate from current standard practice.
Residual pump blood management post aortic cannula removalProcedure or surgery
All residual pump blood will be processed with a bedside red cell washing device (Cell Saver). The resulting total volume of concentrated red cells will be infused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Administration of additional protamine is not required due to the low concentrations of heparin in the resulting product.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Residual pump blood management post aortic cannula removal Receives: Procedure: Residual pump blood management post aortic cannula removal |
| 2 | Experimental | Residual pump blood management post aortic cannula removal Receives: Procedure: Residual pump blood management post aortic cannula removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total perioperative blood loss
Measured: During surgery
Secondary outcomes (1)
Components of the hemostatic profile will be compared between groups as secondary outcome variables
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2010
- Study completionAug 2010
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Norbert Froese, MD, Principal investigator, University of British ColumbiaJohn Wu, Study director, University of British ColumbiaJacques LeBlanc, Study director, University of British ColumbiaAndrew Campbell, Study director, University of British ColumbiaDoug Salt, Study director, University of British ColumbiaPascal Lavoie, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624611
- Sponsor's protocol ID
- H07-01444
- Status last verified
- Apr 2011
- First submitted
- 13 Feb 2008
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Cardiac Surgery Blood Loss: Effect of Washing Residual Cardiopulmonary Bypass Circuit Blood Red Cells Prior to Re-infusion. A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT00624611
- Acronym / sponsor ID
- H07-01444
- Conditions
- Cardiopulmonary Bypass
- Keywords
- CPB, red blood cell washing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Feb 2008 (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.
When a child undergoes heart surgery, a heart lung machine is used to keep blood flowing while the child's own heart is stopped. After surgery, a significant amount of the child's own blood is left in this machine. In the case of small children, the relative amount of blood potentially lost to the child in this way is very large.
In older children, and those who have undergone less complicated surgery, this blood can all returned to the child. Giving the child back his or her own blood makes is less likely that the child will need a transfusion of donated blood.
However, in younger children, or in children who have undergone more complicated surgery, most or all of this blood is thrown away. This is because of worry that returning this blood may cause bleeding, and excessive bleeding is one of the most feared complications of heart surgery.
This project will explore a method whereby the red blood cells left in the heart lung machine can be returned to children without increasing the risk of bleeding. It will also carefully examine the exact causes of higher bleeding risk in children getting their own blood back so that in the future, all children can have their own blood returned at the end of surgery.
Detailed description
The primary hypothesis of this study is that in our study population, compared to re-infusion of residual CPB blood, re-infusion of only the red cell component of residual CPB blood, causes a lesser defect in clotting, leading to decreased hemorrhage and less post-operative blood loss.
The secondary objectives of this project are to document the effects on the clotting system of pump blood re-infusion by means of in laboratory testing. This work has not been done and is of crucial importance to future optimization of the use of pump blood. We expect to detect and quantify with significant accuracy any increased bleeding risk with our hemostatic profiling. This information will be invaluable in planning the safe introduction of residual CPB blood re-infusion smaller children and those with increase risk of postoperative blood loss. Furthermore, we will determine whether or not any of the potentially beneficial effects to the clotting system of returning all components of residual CPB blood, such as an increase in functioning platelets, or an increase in clotting factors, are realized. This information will determine the utility of pursuing means by which these non red cell components of residual CPB blood can be safely re-infused.
Induction of anesthesia, arterial and venous vascular catheter placement, heparin administration, cardiopulmonary bypass machine setup and priming, conduct of CPB, ultrafiltration of blood during CPB, post-CPB protamine administration and post-CPB blood ultrafiltration will all be standardized as per current clinical practice.
Residual CPB blood will be processed and re-infused according to group allocation.
Intravascular volume in the form of crystalloid, and blood products will be administered over and above the study residual blood product infusion as required according to protocol.
Subjects will have blood sampled for hemoglobin concentration immediately after induction of anesthesia and again 24 hours following their surgery.
Arterial blood will be sampled from the patient for a hemostatic profile, outlined in the adjacent text box, after separation from CPB and prior to initiation of residual CPB blood product re-infusion. A second sample will be obtained when re-infusion of residual CPB blood product is complete. In addition, a hemostatic profile will be run directly on a sample of the residual CPB blood product.
Subject demographic data, surgical diagnosis and procedures, CPB data, all medication, blood product and intravenous fluid administration, total volume of study fluid administered, blood lost during surgery to sponges and suction and 24 hour mediastinal drainage will be recorded for all subjects. Any cases of incomplete re-infusion of study blood product will be noted as will the reason for the occurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Residual pump blood management post aortic cannula removalResidual pump blood management post aortic cannula removal |
| 2 | Experimental | Procedure: Residual pump blood management post aortic cannula removalResidual pump blood management post aortic cannula removal |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 15 and 30 kg undergoing cardiac surgery requiring cardiopulmonary bypass at British Columbia's Children's Hospital.
- All children will be between 2 and 10 years of age.
- Surgery will only involve single atriotomy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Residual pump blood management post aortic cannula removalResidual pump blood will be maximally hemoconcentrated by further ultrafiltation within the CPB machine. Resulting hematocrit will be approximately 0.4. The total residual pump blood volume, approximately 300ml, will be reinfused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Additional protamine sulfate will be given every 30 minutes during the infusion, .03 mg/ml of residual pump blood. Procedures in this group do not deviate from current standard practice. | Procedure or surgery | 1 |
| Residual pump blood management post aortic cannula removalAll residual pump blood will be processed with a bedside red cell washing device (Cell Saver). The resulting total volume of concentrated red cells will be infused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Administration of additional protamine is not required due to the low concentrations of heparin in the resulting product. | Procedure or surgery | 2 |
Primary outcome
Total perioperative blood loss
Time frame: During surgery
1 secondary outcome
Components of the hemostatic profile will be compared between groups as secondary outcome variables
Time frame: 24 hours
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 14 Apr 2011.
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Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
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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.
Norbert Froese, MD principal investigator
University of British Columbia
John Wu study director
University of British Columbia
Jacques LeBlanc study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Residual pump blood management post aortic cannula removal in people with Cardiopulmonary Bypass, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 0 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 14 Apr 2011. 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 Canada. 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?
Total perioperative blood loss (time frame: During 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 14 Apr 2011.