Cardiopulmonary Circuits in the Pediatric Population
|ClinicalTrials.gov Identifier: NCT00208728|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 27, 2013
|First Submitted Date ICMJE||September 13, 2005|
|First Posted Date ICMJE||September 21, 2005|
|Last Update Posted Date||November 27, 2013|
|Study Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Decrease in platelet activation, platelet sequestration and fibrinolysis.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00208728 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Decrease in post-operative coagulopathy as measured by bleeding and blood product use.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Cardiopulmonary Circuits in the Pediatric Population|
|Official Title ICMJE||Prospective Evaluation of Modified Cardiopulmonary Bypass Circuits in the Pediatric Population|
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.
The goal of this study is to compare the PC/SMART 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 PC/SMART 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 GPIIb/IIIa 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 Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||June 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00208728|
|Other Study ID Numbers ICMJE||0227-2003|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Brian Kogon, Emory University|
|Study Sponsor ICMJE||Emory University|
|Collaborators ICMJE||Not Provided|
|PRS Account||Emory University|
|Verification Date||November 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP