Clinical trial NCT00359398: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cardiac Surgical Procedures
Cardiopulmonary Bypass
Blood Platelet Disorders
Blood Coagulation Disorders
Keywords: Cardiopulmonary bypass
Blood component removal
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2006-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser
timeFrame: At end of surgery (usually <1 day)
Secondary outcomes:
measure: Volume of blood lost into chest drains during first 24 post-operative hours
timeFrame: 24 hours
measure: Volume of blood product administered during first 24 post-operative hours
timeFrame: 24 hours
measure: Length of stay in the intensive care unit (ICU)
timeFrame: Usually < 30 days
measure: ICU mortality
timeFrame: Usually < 30 days
measure: Incidence of surgical re-exploration
timeFrame: Hospital admission (usually < 30 days)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Simon J Finney, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Andrea Kelleher, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Judith Hall
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Simon Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References: