PediatricNCT00208728
Cardiopulmonary Circuits in the Pediatric Population
A study testing PC/SMART cardiopulmonary bypass circuit and PMEA modified cardiopulmonary bypass circuit in people with Pediatric and Cardiac Surgery, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric, Cardiac Surgery
- What is being tested?
- PC/SMART cardiopulmonary bypass circuit and PMEA modified cardiopulmonary bypass circuit
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients electively scheduled for first time cardiac surgery requiring cardiopulmonary bypass
- weight between 5 kg and 10 kg
- signed informed consent
Who cannot join
- patients requiring emergent cardiac surgery
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Pediatric, Cardiac Surgery
- Being tested
- PC/SMART cardiopulmonary bypass circuit, PMEA modified cardiopulmonary bypass circuit, Standard of care uncoated cardiopulmonary bypass circuit
- Keywords
- pediatric, congenital heart disease, cardiac surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC/SMART cardiopulmonary bypass circuitDevice
PMEA modified cardiopulmonary bypass circuitDevice
Standard of care uncoated cardiopulmonary bypass circuitDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in platelet activation, platelet sequestration and fibrinolysis.
Secondary outcomes (1)
Decrease in post-operative coagulopathy as measured by bleeding and blood product use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kogon, Emory University
- Investigators
- Paul Kirshbom, MD, Principal investigator, Emory University and Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208728
- Sponsor's protocol ID
- 0227-2003
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 27 Nov 2013
- Results posted
- No
Publications
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.
PubMed 8507971Defraigne 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.
PubMed 11156123Gunaydin 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.
PubMed 12238845Gu 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.
PubMed 9594864Butler 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.
PubMed 8431082
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Modified Cardiopulmonary Bypass Circuits in the Pediatric Population
- ClinicalTrials.gov ID
- NCT00208728
- Acronym / sponsor ID
- 0227-2003
- Conditions
- Pediatric, Cardiac Surgery
- Keywords
- pediatric, congenital heart disease, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Jun 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients electively scheduled for first time cardiac surgery requiring cardiopulmonary bypass
- weight between 5 kg and 10 kg
- signed informed consent
Key exclusion criteria (6 listed)
- patients requiring emergent cardiac surgery
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC/SMART cardiopulmonary bypass circuit | Device | – |
| PMEA modified cardiopulmonary bypass circuit | Device | – |
| Standard of care uncoated cardiopulmonary bypass circuit | Device | – |
Primary outcome
Decrease in platelet activation, platelet sequestration and fibrinolysis.
1 secondary outcome
Decrease in post-operative coagulopathy as measured by bleeding and blood product use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
- Background: PubMed 8507971Edmunds 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.
- Background: PubMed 11156123Defraigne 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.
- Background: PubMed 12238845Gunaydin 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.
- Background: PubMed 9594864Gu 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.
- Background: PubMed 8431082Butler 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.
Related trials for Pediatric
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Kirshbom, MD principal investigator
Emory University and Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC/SMART cardiopulmonary bypass circuit and PMEA modified cardiopulmonary bypass circuit in people with Pediatric and Cardiac Surgery, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in platelet activation, platelet sequestration and fibrinolysis.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208728, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.