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Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery

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

Tracking Information
First Submitted Date  ICMJE August 1, 2006
First Posted Date  ICMJE August 2, 2006
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE August 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: August 1, 2006)
Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Surgical Procedures
  • Cardiopulmonary Bypass
  • Blood Platelet Disorders
  • Blood Coagulation Disorders
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2009)
30
Original Enrollment  ICMJE
 (submitted: August 1, 2006)
180
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359398
Other Study ID Numbers  ICMJE 2006IC003B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor  ICMJE Royal Brompton & Harefield NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP