Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2003-05-31
2005-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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PC/SMART cardiopulmonary bypass circuit
PMEA modified cardiopulmonary bypass circuit
Standard of care uncoated cardiopulmonary bypass circuit
Eligibility Criteria
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Inclusion Criteria
* weight between 5 kg and 10 kg
* signed informed consent
Exclusion Criteria
* patients who have undergone prior cardiothoracic surgery
* documented coagulation disorders
* use of anticoagulant drugs or anti-platelet agents within 48 hours of surgery
* patients who require more than 4 hours of CPB or require a return to CPB
* informed consent not obtained.
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Brian Kogon
Principal Investigator
Principal Investigators
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Paul Kirshbom, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University and Children's Healthcare of Atlanta
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Countries
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References
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Edmunds LH Jr. Blood-surface interactions during cardiopulmonary bypass. J Card Surg. 1993 May;8(3):404-10. doi: 10.1111/j.1540-8191.1993.tb00384.x.
Defraigne JO, Pincemail J, Dekoster G, Larbuisson R, Dujardin M, Blaffart F, David JL, Limet R. SMA circuits reduce platelet consumption and platelet factor release during cardiac surgery. Ann Thorac Surg. 2000 Dec;70(6):2075-81. doi: 10.1016/s0003-4975(00)01838-5.
Gunaydin S, Farsak B, Kocakulak M, Sari T, Yorgancioglu C, Zorlutuna Y. Clinical performance and biocompatibility of poly(2-methoxyethylacrylate)-coated extracorporeal circuits. Ann Thorac Surg. 2002 Sep;74(3):819-24. doi: 10.1016/s0003-4975(02)03796-7.
Gu YJ, Boonstra PW, Rijnsburger AA, Haan J, van Oeveren W. Cardiopulmonary bypass circuit treated with surface-modifying additives: a clinical evaluation of blood compatibility. Ann Thorac Surg. 1998 May;65(5):1342-7. doi: 10.1016/s0003-4975(98)00223-9.
Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. doi: 10.1016/0003-4975(93)91048-r.
Other Identifiers
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0227-2003
Identifier Type: -
Identifier Source: org_study_id