Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359398
Status:
TERMINATED
Last Update Posted:
2016-04-14
First Post:
2006-08-01
Brief Title:
Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
Post-operative Administration of Platelet Rich Plasma Sequestered Prior to Cardiopulmonary Bypass Reduces the Coagulopathy Associated With Complex Cardiac Surgery
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding expired low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 plateletplasma sequestration or not Patients randomised to undergo sequestration will have 14 mLKg blood taken The blood will be separated into red cells and plateletsplasma Anaemia would be prevented by returning the processed red blood cells to the patient We will store platelets at 20-24Croom 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
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 plateletplasma sequestration or not Patients randomised to undergo sequestration will have 14 mLKg blood taken The blood will be separated into red cells and plateletsplasma Anaemia would be prevented by returning the processed red blood cells to the patient We will store platelets at 20-24Croom 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None