Acquired Platelet Function DisorderNCT01648712
Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery
A study testing Balance surface, Carmeda heparin-coated surface and non -heparin extracorporeal pediatric device for operation in people with Acquired Platelet Function Disorder, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial summary
Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system activation. Platelet dysfunction is commonly observed after procedures performed under cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding in the postoperative period. Read more about this study
- Who is it for?
- Ages 30 days to 5 years
- Conditions the study is for
- Acquired Platelet Function Disorder
- What is being tested?
- Balance surface, Carmeda heparin-coated surface and non -heparin extracorporeal pediatric device for operation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Apr 2015
- 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 30 days to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants/children (weighting less than 18 Kg) undergoing surgical repair of congenital heart defects on CPB, presenting a saturation > 85% preoperatively.
Who cannot join
- Newborns, infants/children with Down syndrome, other syndromes or chromosomal abnormalities prematurity,
- use of circulatory arrest,
- expected perfusion time < 1 hour, documented coagulation disorders, use of anticoagulant or antiplatelet drugs within 48 hours of surgery, previous heart surgery and procedures requiring a return on CPB (2 or more CPB runs),
- cyanosis defined as oxygen saturation lower than 85%.
Trial locations and contacts
1 site in 1 country.
About this study
Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system activation. Platelet dysfunction is commonly observed after procedures performed under cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding in the postoperative period.
Coating of the surface has been shown to diminish these effects.Biocompatible surfaces, extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium to provide thromboresistance and enhanced blood compatibility. Recently, a new physiologic non heparin coating with different functional aspects was developed as an alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood. The aim of this study is to compare the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation.
Read the detailed description
Platelet dysfunction is commonly observed after procedures performed under cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding in the postoperative period.
Coating of the surface has been shown to diminish these effects. Since the coagulation system and platelets are involved in the blood activation process, a coating might be a valuable approach to inhibit the different reactions. Improving the biocompatibility of the system by reduction of contact activation of blood elements is of significant importance, especially for neonates and infants who are more susceptible to the deleterious effects of extracorporeal circulation (ECC). Biocompatible surfaces extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium to provide thromboresistance and enhanced blood compatibility. These biocompatible surfaces mitigate the foreign body response that occurs when blood comes in contact with non- endothelial surfaces.
Recently, a new physiologic non heparin coating with different functional aspects was developed as an alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood.
- Conditions
- Acquired Platelet Function Disorder
- Being tested
- Balance surface, Carmeda heparin-coated surface, non -heparin extracorporeal pediatric device for operation
- Keywords
- extracorporeal circuit, platelet function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance surface, Carmeda heparin-coated surfaceDevice
This study compares the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation.
Balance arm group recieved like intervention a Balance circuit
non -heparin extracorporeal pediatric device for operationDevice
The carmeda arm group received like intervention the Carmeda circuit
| Study group | Role | What they receive |
|---|---|---|
| Balance Circuit | Other | 24 patients will be assigned to the Balance group , using a non -heparin extracorporeal pediatric device for operation . The intervention is to use the Balance circuit for this arm Receives: Device: non -heparin extracorporeal pediatric device for operation |
| Carmeda Circuit | Other | 24 patients will be assigned to the Carmeda group, using a coated heparin extracorporeal pediatric device for operation.
The intervention is to use the Carmeda circuit for this arm. The intervention is the Carmeda circuit. Receives: Device: Balance surface, Carmeda heparin-coated surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the difference in levels of ß thromboglobulin (ß TG) at T2 (15 min after end of bypass) between the two groups.
Assuming a reduction of 30% of ß TG in infants treated with Balance TM , a total of 64 infants, 32 on each arm, will be needed to detect a Δ = 246 (mean ß TG = 820ng/ml in group Carmeda and mean ß TG =574ng/ml in group Balance; standard deviation=300) , in the level of ß TG at T2 with a two sided p=0.05 and a power of 80%.
Taking in to account the use of non parametric test, we estimated an increase of the calculated sample size of 15%, yielding a total sample size of 74 patients.
Measured: six months
Secondary outcomes (1)
Platelet mapping by thromboelastography (Hemoscope, Medtronic) will be performed at the following times: T0,T1,T2,T3.
Flow cytometry will be analysed at T0, T1,T2. Fibrinogen levels, platelet count, prothrombin time, thrombin-antithrombin complex (TAT), F 1+2, PF4 , will be analysed at each time of the study.
Differences of bleeding, and transfusion of any blood product, during the first postoperative 24 hours, will be collected.
Analysis of differences of activation at different times, for two different temperatures, used for CPB in the two centers.
Need of surgical review for bleeding, time of intubation, length of stay in ICU will be analyzed.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: for difficulty to enroll patients in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Platelet Function DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Collaborators
- Bambino Gesù Hospital and Research Institute
- Responsible party
- Principal investigator, Chiara Giorni, Hôpital Necker-Enfants Malades
- Investigators
- Chiara Giorni, M.D., Principal investigator, Hopital Necker Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648712
- Sponsor's protocol ID
- Necker
- Status last verified
- Feb 2021
- First submitted
- 20 Jul 2012
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01648712
- Acronym / sponsor ID
- Necker
- Conditions
- Acquired Platelet Function Disorder
- Keywords
- extracorporeal circuit, platelet function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for difficulty to enroll patients in the study
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Collaborators
- Bambino Gesù Hospital and Research Institute
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Jul 2012 (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.
Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system activation. Platelet dysfunction is commonly observed after procedures performed under cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding in the postoperative period.
Coating of the surface has been shown to diminish these effects.Biocompatible surfaces, extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium to provide thromboresistance and enhanced blood compatibility. Recently, a new physiologic non heparin coating with different functional aspects was developed as an alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood. The aim of this study is to compare the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation.
Detailed description
Platelet dysfunction is commonly observed after procedures performed under cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding in the postoperative period.
Coating of the surface has been shown to diminish these effects. Since the coagulation system and platelets are involved in the blood activation process, a coating might be a valuable approach to inhibit the different reactions. Improving the biocompatibility of the system by reduction of contact activation of blood elements is of significant importance, especially for neonates and infants who are more susceptible to the deleterious effects of extracorporeal circulation (ECC). Biocompatible surfaces extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium to provide thromboresistance and enhanced blood compatibility. These biocompatible surfaces mitigate the foreign body response that occurs when blood comes in contact with non- endothelial surfaces.
Recently, a new physiologic non heparin coating with different functional aspects was developed as an alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Circuit | Other | Device: non -heparin extracorporeal pediatric device for operation24 patients will be assigned to the Balance group , using a non -heparin extracorporeal pediatric device for operation . The intervention is to use the Balance circuit for this arm |
| Carmeda Circuit | Other | Device: Balance surface, Carmeda heparin-coated surface24 patients will be assigned to the Carmeda group, using a coated heparin extracorporeal pediatric device for operation. The intervention is to use the Carmeda circuit for this arm. The intervention is the Carmeda circuit. |
Who may qualify
- Ages
- 30 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants/children (weighting less than 18 Kg) undergoing surgical repair of congenital heart defects on CPB, presenting a saturation > 85% preoperatively.
Key exclusion criteria (4 listed)
- Newborns, infants/children with Down syndrome, other syndromes or chromosomal abnormalities prematurity,
- use of circulatory arrest,
- expected perfusion time < 1 hour, documented coagulation disorders, use of anticoagulant or antiplatelet drugs within 48 hours of surgery, previous heart surgery and procedures requiring a return on CPB (2 or more CPB runs),
- cyanosis defined as oxygen saturation lower than 85%.
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 |
|---|---|---|
| Balance surface, Carmeda heparin-coated surfaceThis study compares the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation. Balance arm group recieved like intervention a Balance circuit | Device | Carmeda Circuit |
| non -heparin extracorporeal pediatric device for operationThe carmeda arm group received like intervention the Carmeda circuit | Device | Balance Circuit |
Primary outcome
The primary endpoint will be the difference in levels of ß thromboglobulin (ß TG) at T2 (15 min after end of bypass) between the two groups.
Time frame: six months
Assuming a reduction of 30% of ß TG in infants treated with Balance TM , a total of 64 infants, 32 on each arm, will be needed to detect a Δ = 246 (mean ß TG = 820ng/ml in group Carmeda and mean ß TG =574ng/ml in group Balance; standard deviation=300) , in the level of ß TG at T2 with a two sided p=0.05 and a power of 80%. Taking in to account the use of non parametric test, we estimated an increase of the calculated sample size of 15%, yielding a total sample size of 74 patients.
1 secondary outcome
Platelet mapping by thromboelastography (Hemoscope, Medtronic) will be performed at the following times: T0,T1,T2,T3.
Time frame: six months
Results and safety
The study was stopped early (reason given: for difficulty to enroll patients in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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RecruitingObservational study
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Not yet recruitingObservational study
Flow-Based Platelet Function Assessment Using Total Thrombus-Formation Analysis System (T-TAS) and Early Bleeding After Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Perioperative Bleeding, Coagulopathy During Cardiac Surgery
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.
Chiara Giorni, M.D. principal investigator
Hopital Necker Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance surface, Carmeda heparin-coated surface and non -heparin extracorporeal pediatric device for operation in people with Acquired Platelet Function Disorder, run by Hôpital Necker-Enfants Malades at 1 site in France.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Feb 2021. 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 France. 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 was stopped early (reason given: for difficulty to enroll patients in the study). Results are not available in the source record.
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?
The primary endpoint will be the difference in levels of ß thromboglobulin (ß TG) at T2 (15 min after end of bypass) between the two groups. (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2021.