search
Back to results

Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery

Primary Purpose

Cardiac Surgical Procedures, Cardiopulmonary Bypass, Blood Platelet Disorders

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Platelet rich plasma sequestration
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgical Procedures focused on measuring Cardiopulmonary bypass, Blood component removal

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Platelet sequestration

Standard care

Arm Description

Sequestration of platelet rich plasma before cardiopulmonary bypass

No platelet rich plasma sequestration undertaken before cardiopulmonary bypass (usual practice)

Outcomes

Primary Outcome Measures

Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser

Secondary Outcome Measures

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 in the intensive care unit (ICU)
ICU mortality
Incidence of surgical re-exploration

Full Information

First Posted
August 1, 2006
Last Updated
April 13, 2016
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT00359398
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Funding expired, low recruitment
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgical Procedures, Cardiopulmonary Bypass, Blood Platelet Disorders, Blood Coagulation Disorders
Keywords
Cardiopulmonary bypass, Blood component removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet sequestration
Arm Type
Experimental
Arm Description
Sequestration of platelet rich plasma before cardiopulmonary bypass
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
No platelet rich plasma sequestration undertaken before cardiopulmonary bypass (usual practice)
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma sequestration
Other Intervention Name(s)
Haemonetics cell salavage system
Intervention Description
Venesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma.
Primary Outcome Measure Information:
Title
Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser
Time Frame
At end of surgery (usually <1 day)
Secondary Outcome Measure Information:
Title
Volume of blood lost into chest drains during first 24 post-operative hours
Time Frame
24 hours
Title
Volume of blood product administered during first 24 post-operative hours
Time Frame
24 hours
Title
Length of stay in the intensive care unit (ICU)
Time Frame
Usually < 30 days
Title
ICU mortality
Time Frame
Usually < 30 days
Title
Incidence of surgical re-exploration
Time Frame
Hospital admission (usually < 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon J Finney, MBChB, PhD
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Kelleher, MBBS
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith Hall
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon Davidson, PhD
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6LY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery

We'll reach out to this number within 24 hrs