Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery

This study has been terminated.
(Funding expired, low recruitment)
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00359398
First received: August 1, 2006
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Cardiac Surgical Procedures
Cardiopulmonary Bypass
Blood Platelet Disorders
Blood Coagulation Disorders
Procedure: Platelet rich plasma sequestration
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Post-operative Administration of Platelet Rich Plasma Sequestered Prior to Cardiopulmonary Bypass Reduces the Coagulopathy Associated With Complex Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser [ Time Frame: At end of surgery (usually <1 day) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Volume of blood lost into chest drains during first 24 post-operative hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Volume of blood product administered during first 24 post-operative hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Length of stay in the intensive care unit (ICU) [ Time Frame: Usually < 30 days ] [ Designated as safety issue: Yes ]
  • ICU mortality [ Time Frame: Usually < 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of surgical re-exploration [ Time Frame: Hospital admission (usually < 30 days) ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2006
Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Platelet sequestration
Sequestration of platelet rich plasma before cardiopulmonary bypass
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
No Intervention: Standard care
No platelet rich plasma sequestration undertaken before cardiopulmonary bypass (usual practice)

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359398

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
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
  More Information

No publications provided

Responsible Party: Wendy Butcher, Head of Research and Development, Royal Brompton Hospital
ClinicalTrials.gov Identifier: NCT00359398     History of Changes
Other Study ID Numbers: 2006IC003B
Study First Received: August 1, 2006
Last Updated: September 18, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Cardiopulmonary bypass
Blood component removal

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Platelet Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on July 22, 2014