Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery

Cardiopulmonary Bypass Clinical Trial

Official title:

Post-operative Administration of Platelet Rich Plasma Sequestered Prior to Cardiopulmonary Bypass Reduces the Coagulopathy Associated With Complex Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359398
• Other study ID #: 2006IC003B
• Status: Terminated
• Phase: Phase 2
• First received: August 1, 2006
• Last updated: April 13, 2016
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: April 2016
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Platelet rich plasma sequestration
Venesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser		At end of surgery (usually <1 day)	No
Secondary	Volume of blood lost into chest drains during first 24 post-operative hours		24 hours	Yes
Secondary	Volume of blood product administered during first 24 post-operative hours		24 hours	Yes
Secondary	Length of stay in the intensive care unit (ICU)		Usually < 30 days	Yes
Secondary	ICU mortality		Usually < 30 days	Yes
Secondary	Incidence of surgical re-exploration		Hospital admission (usually < 30 days)	Yes