Cardiac Surgical ProceduresPhase 2NCT00359398
Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery
A Phase 2 study testing Platelet rich plasma sequestration in people with Cardiac Surgical Procedures and Cardiopulmonary Bypass, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Excessive bleeding is common after cardiac surgery. This may result in patients receiving a blood transfusion or suffering the life-threatening complication of cardiac tamponade. Tamponade is when excessive bleeding compresses the heart and prevents it from pumping properly. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Blood Platelet Disorders
- What is being tested?
- Platelet rich plasma sequestration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2006to Jul 2009
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients undergoing cardiac surgery that involves:
- Repeat median sternotomy
- Mitral valve repair
- Double valve operations
- Combined valve and coronary surgery
- Anticipated prolonged cardiopulmonary bypass
Who cannot join
- Pre-operative anaemia
- Pre-operative thrombocytopenia
- Unstable angina
- Anti-platelet therapy (e.g. aspirin, clopidogrel) within the previous 7 days
- Known or symptomatic cerebrovascular disease
- Known disorders of haemostasis
- Aprotinin sensitivity
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Administration of Platelet Rich Plasma Sequestered Prior to Cardiopulmonary Bypass Reduces the Coagulopathy Associated With Complex Cardiac Surgery
Excessive bleeding is common after cardiac surgery. This may result in patients receiving a blood transfusion or suffering the life-threatening complication of cardiac tamponade. Tamponade is when excessive bleeding compresses the heart and prevents it from pumping properly. A major reason for the bleeding is the damage done to platelets by the cardiopulmonary bypass (CPB) machine. Often patients receive platelets and plasma from blood donors to try to reduce the bleeding post-operatively. The investigators plan to take platelets and plasma from patients before they are damaged. They would then return these 'undamaged' sequestered platelets to the patients after the bypass machine is no longer needed. Therefore, the investigators' primary question is whether platelet sequestration would reduce the bleeding problems that occur following cardiac surgery. They will evaluate bleeding problems using thromboelastography, which provides a comprehensive assessment of both how blood clots form and their strength. If sequestration reduces bleeding problems following cardiac surgery then it may reduce the chance of patients receiving blood products from donors. Although donated blood is thoroughly tested, its use does expose patients to the risk of transfusion errors, blood borne infections and reactions. Avoiding its use would be very desirable.
Read the detailed description
Hypothesis:
Patients undergoing repeat median sternotomy or requiring prolonged cardiopulmonary bypass (CPB) often develop a coagulopathy at the end of surgery. We propose sequestering plasma and platelets from these patients prior to CPB and thus prior to the dilution and platelet damage that occurs with CPB. We hypothesise that if these plasma and platelets are stored properly during CPB, and administered at the end of the operation, they will reduce any coagulopathy and the associated bleeding.
Study population:
Patients undergoing repeat median sternotomy, mitral valve repair, double valve operations, aortic surgery, or combined valve and coronary artery surgery.
Exclusion criteria will include those with anaemia, thrombocytopenia, unstable angina, anti-platelet therapy within the previous seven days, known or symptomatic cerebrovascular disease, known disorders of haemostasis, aprotinin sensitivity and pregnancy.
Intervention:
Patients will be randomised by a closed envelope technique to receive platelet/plasma sequestration or not. Patients randomised to undergo sequestration will have 14 mL/Kg blood taken. The blood will be separated into red cells and platelets/plasma. Anaemia would be prevented by returning the processed red blood cells to the patient. We will store platelets at 20-24°C/room temperature on a platelet rocker according to guidelines from the National Blood Service.
Assessment of coagulation:
Patients' coagulation status will be evaluated before and after surgery. Four methods will be employed to comprehensively assess the coagulation system: platelet counts and conventional clotting studies; heparin levels; thromboelastography; and platelet function analyser.
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Blood Platelet Disorders, Blood Coagulation Disorders
- Being tested
- Platelet rich plasma sequestration
- Keywords
- Cardiopulmonary bypass, Blood component removal
- Medical subject headings
- Blood Platelet Disorders, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma sequestrationProcedure or surgery
Also called Haemonetics cell salavage system
Venesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma.
| Study group | Role | What they receive |
|---|---|---|
| Platelet sequestration | Experimental | Sequestration of platelet rich plasma before cardiopulmonary bypass Receives: Procedure: Platelet rich plasma sequestration |
| Standard care | No intervention | No platelet rich plasma sequestration undertaken before cardiopulmonary bypass (usual practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser
Measured: At end of surgery (usually <1 day)
Secondary outcomes (5)
Volume of blood lost into chest drains during first 24 post-operative hours
Measured: 24 hours
Volume of blood product administered during first 24 post-operative hours
Measured: 24 hours
Length of stay in the intensive care unit (ICU)
Measured: Usually < 30 days
ICU mortality
Measured: Usually < 30 days
Incidence of surgical re-exploration
Measured: Hospital admission (usually < 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Funding expired, low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon J Finney, MBChB, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustAndrea Kelleher, MBBS, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustJudith Hall, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustSimon Davidson, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359398
- Sponsor's protocol ID
- 2006IC003B
- Status last verified
- Apr 2016
- First submitted
- 1 Aug 2006
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Administration of Platelet Rich Plasma Sequestered Prior to Cardiopulmonary Bypass Reduces the Coagulopathy Associated With Complex Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00359398
- Acronym / sponsor ID
- 2006IC003B
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Blood Platelet Disorders, Blood Coagulation Disorders
- Keywords
- Cardiopulmonary bypass, Blood component removal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding expired, low recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Aug 2006 (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.
Excessive bleeding is common after cardiac surgery. This may result in patients receiving a blood transfusion or suffering the life-threatening complication of cardiac tamponade. Tamponade is when excessive bleeding compresses the heart and prevents it from pumping properly. A major reason for the bleeding is the damage done to platelets by the cardiopulmonary bypass (CPB) machine. Often patients receive platelets and plasma from blood donors to try to reduce the bleeding post-operatively. The investigators plan to take platelets and plasma from patients before they are damaged. They would then return these 'undamaged' sequestered platelets to the patients after the bypass machine is no longer needed. Therefore, the investigators' primary question is whether platelet sequestration would reduce the bleeding problems that occur following cardiac surgery. They will evaluate bleeding problems using thromboelastography, which provides a comprehensive assessment of both how blood clots form and their strength. If sequestration reduces bleeding problems following cardiac surgery then it may reduce the chance of patients receiving blood products from donors. Although donated blood is thoroughly tested, its use does expose patients to the risk of transfusion errors, blood borne infections and reactions. Avoiding its use would be very desirable.
Detailed description
Hypothesis:
Patients undergoing repeat median sternotomy or requiring prolonged cardiopulmonary bypass (CPB) often develop a coagulopathy at the end of surgery. We propose sequestering plasma and platelets from these patients prior to CPB and thus prior to the dilution and platelet damage that occurs with CPB. We hypothesise that if these plasma and platelets are stored properly during CPB, and administered at the end of the operation, they will reduce any coagulopathy and the associated bleeding.
Study population:
Patients undergoing repeat median sternotomy, mitral valve repair, double valve operations, aortic surgery, or combined valve and coronary artery surgery.
Exclusion criteria will include those with anaemia, thrombocytopenia, unstable angina, anti-platelet therapy within the previous seven days, known or symptomatic cerebrovascular disease, known disorders of haemostasis, aprotinin sensitivity and pregnancy.
Intervention:
Patients will be randomised by a closed envelope technique to receive platelet/plasma sequestration or not. Patients randomised to undergo sequestration will have 14 mL/Kg blood taken. The blood will be separated into red cells and platelets/plasma. Anaemia would be prevented by returning the processed red blood cells to the patient. We will store platelets at 20-24°C/room temperature on a platelet rocker according to guidelines from the National Blood Service.
Assessment of coagulation:
Patients' coagulation status will be evaluated before and after surgery. Four methods will be employed to comprehensively assess the coagulation system: platelet counts and conventional clotting studies; heparin levels; thromboelastography; and platelet function analyser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet sequestration | Experimental | Procedure: Platelet rich plasma sequestrationSequestration of platelet rich plasma before cardiopulmonary bypass |
| Standard care | No intervention | –No platelet rich plasma sequestration undertaken before cardiopulmonary bypass (usual practice) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Repeat median sternotomy
- Mitral valve repair
- Double valve operations
- Combined valve and coronary surgery
- Anticipated prolonged cardiopulmonary bypass
Key exclusion criteria (8 listed)
- Pre-operative anaemia
- Pre-operative thrombocytopenia
- Unstable angina
- Anti-platelet therapy (e.g. aspirin, clopidogrel) within the previous 7 days
- Known or symptomatic cerebrovascular disease
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 |
|---|---|---|
| Platelet rich plasma sequestrationAlso: Haemonetics cell salavage systemVenesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma. | Procedure or surgery | Platelet sequestration |
Primary outcome
Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser
Time frame: At end of surgery (usually <1 day)
5 secondary outcomes
Volume of blood lost into chest drains during first 24 post-operative hours
Time frame: 24 hours
Volume of blood product administered during first 24 post-operative hours
Time frame: 24 hours
Length of stay in the intensive care unit (ICU)
Time frame: Usually < 30 days
ICU mortality
Time frame: Usually < 30 days
Incidence of surgical re-exploration
Time frame: Hospital admission (usually < 30 days)
Results and safety
The study was stopped early (reason given: Funding expired, low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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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.
Simon J Finney, MBChB, PhD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
Andrea Kelleher, MBBS principal investigator
Royal Brompton & Harefield NHS Foundation Trust
Judith Hall principal investigator
Royal Brompton & Harefield NHS Foundation Trust
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 Platelet rich plasma sequestration in people with Cardiac Surgical Procedures and Cardiopulmonary Bypass, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 8 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 14 Apr 2016. 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 Kingdom. 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: Funding expired, low recruitment). 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?
Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser (time frame: At end of surgery (usually <1 day)). 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 2016.