Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery

• ClinicalTrials.gov Identifier: NCT00359398
• Recruitment Status: Terminated
• First Posted: August 2, 2006
• Last Update Posted: April 14, 2016
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Information provided by (Responsible Party): Royal Brompton & Harefield NHS Foundation Trust

Tracking Information

• First Submitted Date: August 1, 2006
• First Posted Date: August 2, 2006
• Last Update Posted Date: April 14, 2016
• Study Start Date: August 2006
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 14, 2007): Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser [ Time Frame: At end of surgery (usually <1 day) ]
• Original Primary Outcome Measures (submitted: August 1, 2006): Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser

Current Secondary Outcome Measures (submitted: June 11, 2007)

• 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) ]

Original Secondary Outcome Measures (submitted: August 1, 2006)

• Incidence of surgical re-exploration
• Volume of blood lost into chest drains during first 24 post-operative hours
• Volume of blood product administered during first 24 post-operative hours
• Length of stay on the intensive care unit
• ICU mortality

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery
• Official Title: Post-operative Administration of Platelet Rich Plasma Sequestered Prior to Cardiopulmonary Bypass Reduces the Coagulopathy Associated With Complex Cardiac Surgery
• Brief 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. 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Cardiac Surgical Procedures
• Cardiopulmonary Bypass
• Blood Platelet Disorders
• Blood Coagulation Disorders

Intervention

Procedure: Platelet rich plasma sequestration

Venesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma.

Other Name: Haemonetics cell salavage system

Study Arms

• Experimental: Platelet sequestration
  Sequestration of platelet rich plasma before cardiopulmonary bypass
  Intervention: Procedure: Platelet rich plasma sequestration
• No Intervention: Standard care
  No platelet rich plasma sequestration undertaken before cardiopulmonary bypass (usual practice)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 18, 2009): 30
• Original Enrollment (submitted: August 1, 2006): 180
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00359398
• Other Study ID Numbers: 2006IC003B
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
• Study Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Not Provided

Investigators

• Principal Investigator: Simon J Finney, MBChB, PhD; Royal Brompton & Harefield NHS Foundation Trust
• Principal Investigator: Andrea Kelleher, MBBS; Royal Brompton & Harefield NHS Foundation Trust
• Principal Investigator: Judith Hall; Royal Brompton & Harefield NHS Foundation Trust
• Principal Investigator: Simon Davidson, PhD; Royal Brompton & Harefield NHS Foundation Trust

• PRS Account: Royal Brompton & Harefield NHS Foundation Trust
• Verification Date: April 2016