Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208728
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2005-09-13
Brief Title:
Cardiopulmonary Circuits in the Pediatric Population
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Prospective Evaluation of Modified Cardiopulmonary Bypass Circuits in the Pediatric Population
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
During open-heart surgery blood flow is supported by a heart-lung machine that both pumps the blood and gives it oxygen A problem associated with a heart-lung machine is the damage to some of the blood caused by protein in the blood cell sticking to the sides of the heart-lung machine tubing This breakdown of the blood cell affects the platelets which help the blood to clot Use of the un-treated circuit will be phased out within the next few years as newer technology is available The use of coated tubing has been shown to decrease problems with post-operative bleeding in the adult population No studies have been done on the pediatric population We plan to perform a prospective randomized study using the un-treated circuits used now the Smart circuit tubing manufactured by Cobe Cardiovascular Inc Arvada CO and the PMEA circuit manufactured by Terumo Corporation Tokyo Japan Randomization will be performed by the perfusionist the person that runs the heart-lung machine in charge of the case No one else will be aware of which circuit is being used There will be no changes in the operation of the heart-lung machine anesthesia or the surgery because of this study
Blood testing that is standard of care and some additional tests will be performed on a small amount of blood drawn from the patient via arterial lines Additional blood sticks will not be required to obtain this sample
Blood testing that is standard of care and some additional tests will be performed on a small amount of blood drawn from the patient via arterial lines Additional blood sticks will not be required to obtain this sample
Detailed Description:
The goal of this study is to compare the PCSMART and PMEA treated circuits against each other and the current clinical standard untreated circuit with regard to blood component damage during CPB
Specific Aims SA1 To determine if the surface modified circuits decrease platelet activation platelet sequestration and fibrinolysis during pediatric cardiac surgery using CPB
Hypothesis 1 Use of a surface modified circuit will attenuate the CPB related decrease in platelet count diminish platelet dysfunction as measured by thromboelastography TEG and decrease fibrinolysis as measured by fibrin-split product levels and TEG
SA2 To determine whether the use of surface modified circuits during pediatric cardiac surgery results in a clinically relevant decrease in post-operative coagulopathy as measured by post-operative bleeding and blood product use
Hypothesis 2 The use of surface modified circuits will result in improved function of the coagulation system yielding less post-operative bleeding and thus fewer blood product transfusions
Methods The study will be a prospective randomized trial in which a total of 90 patients 5-10 kgs undergoing first time cardiac surgery using CPB at Egleston Hospital will be randomized into 3 groups Group 1 will be the control group for whom the current standard unmodified CPB circuit will be used Group 2 will undergo surgery using the PCSMART modified CPB circuit Cobe Cardiovascular Inc Arvada CO Group 3 will undergo surgery using the PMEA modified circuit Terumo Corporation Tokyo Japan
Hypothesis 1 will be tested using the following assays
Total platelet count Hematocrit Prothrombin time PT Activated thromboplastin time aPTT Fibrin split-product level D-dimer level thromboglobulin level ELISA assay Thromboelastography TEG using heparinase to eliminate heparin effect both with and without REOPRO a GPIIbIIIa platelet inhibitor to measure the relative contributions of platelet function and fibrinogen activity to clot formation
Performed at the following time-points
T1 after induction of anesthesia prior to CPB T2 5 minutes after the initiation of CPB T3 at the end of re-warming end of CPB T4 post-bypass five minutes after protamine administration T5 within 24 hours after surgery TEG will not be collected at this time
Hypothesis 2 will be tested by quantifying chest-tube drainage and blood product administration red blood cells platelets fresh frozen plasma and cryoprecipitate over the first 12 hours after weaning off of CPB
Specific Aims SA1 To determine if the surface modified circuits decrease platelet activation platelet sequestration and fibrinolysis during pediatric cardiac surgery using CPB
Hypothesis 1 Use of a surface modified circuit will attenuate the CPB related decrease in platelet count diminish platelet dysfunction as measured by thromboelastography TEG and decrease fibrinolysis as measured by fibrin-split product levels and TEG
SA2 To determine whether the use of surface modified circuits during pediatric cardiac surgery results in a clinically relevant decrease in post-operative coagulopathy as measured by post-operative bleeding and blood product use
Hypothesis 2 The use of surface modified circuits will result in improved function of the coagulation system yielding less post-operative bleeding and thus fewer blood product transfusions
Methods The study will be a prospective randomized trial in which a total of 90 patients 5-10 kgs undergoing first time cardiac surgery using CPB at Egleston Hospital will be randomized into 3 groups Group 1 will be the control group for whom the current standard unmodified CPB circuit will be used Group 2 will undergo surgery using the PCSMART modified CPB circuit Cobe Cardiovascular Inc Arvada CO Group 3 will undergo surgery using the PMEA modified circuit Terumo Corporation Tokyo Japan
Hypothesis 1 will be tested using the following assays
Total platelet count Hematocrit Prothrombin time PT Activated thromboplastin time aPTT Fibrin split-product level D-dimer level thromboglobulin level ELISA assay Thromboelastography TEG using heparinase to eliminate heparin effect both with and without REOPRO a GPIIbIIIa platelet inhibitor to measure the relative contributions of platelet function and fibrinogen activity to clot formation
Performed at the following time-points
T1 after induction of anesthesia prior to CPB T2 5 minutes after the initiation of CPB T3 at the end of re-warming end of CPB T4 post-bypass five minutes after protamine administration T5 within 24 hours after surgery TEG will not be collected at this time
Hypothesis 2 will be tested by quantifying chest-tube drainage and blood product administration red blood cells platelets fresh frozen plasma and cryoprecipitate over the first 12 hours after weaning off of CPB
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