Congenital Heart DiseaseNCT02567786
Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children
A study testing Surgery with CPB, Fresh Frozen Plasma and Plasmalyte in people with Congenital Heart Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. Read more about this study
- Who is it for?
- Ages 2 to 70 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Surgery with CPB, Fresh Frozen Plasma and Plasmalyte
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Jul 2018
- 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 2 to 70 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB
Who cannot join
- Patients with preoperative coagulation abnormalities
- Parental refusal
- Emergency surgery
- Patients with preoperative renal or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children Undergoing Open-heart Surgery: A Double-blind Randomized Controlled Study
Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. In children the volume of pump priming is much higher compared with the patient's circulating blood volume. For this reason the CPB tubing system is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive hemodilution and induced coagulopathy. While this is routinely performed in neonates and small infants, the routine priming of CPB system with FFP has been questioned in several randomized prospective studies in older infants. However, the results of these studies are conflicting. Moreover, they show methodological issues.
- Conditions
- Congenital Heart Disease
- Being tested
- Surgery with CPB, Fresh Frozen Plasma, Plasmalyte
- 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.
Surgery with CPBProcedure or surgery
Fresh Frozen PlasmaOther
PlasmalyteOther
| Study group | Role | What they receive |
|---|---|---|
| Fresh Frozen Plasma | Active comparator | The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells. Receives: Procedure: Surgery with CPB; Other: Fresh Frozen Plasma |
| Plasmalyte | Active comparator | The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells. Receives: Procedure: Surgery with CPB; Other: Plasmalyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bleeding (mL blood in the chest tubes). Significant postoperative bleeding is defined as a bleeding of > 5ml/kg/h in the first 6hours postoperatively.
The exact amount of blood loss in the postoperative period per kilogram weight of child.
Measured: The first 6 hours postoperatively
Increased risk of of donor exposure intraoperatively and postoperatively.
The total number of different packs of allogeneic blood products administered per child.
Measured: The first 6 hours postoperatively
Secondary outcomes (2)
Volume of transfused allogenic blood products (mL).
The total volume of allogeneic blood products per kilogram weight of child.
Measured: The first 6 hours postoperatively
Comparison of Rotem and Multiplate between both groups.
The results of the point-of-care tests ROTEM and Multiplate will be compared between children in the Plasmalyte group and children in the Fresh Frozen Plasma group.
Measured: The first 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion30 Jun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Momeni, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Mona Momeni, MD,PhD, Principal investigator, Université Catholique de Louvain; Cliniques Universitaires Saint Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567786
- Sponsor's protocol ID
- Plasma versus Plasmalyte
- Status last verified
- Dec 2018
- First submitted
- 29 Sep 2015
- Last updated
- 5 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children Undergoing Open-heart Surgery: A Double-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02567786
- Acronym / sponsor ID
- Plasma versus Plasmalyte
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 5 Oct 2015 (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.
Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. In children the volume of pump priming is much higher compared with the patient's circulating blood volume. For this reason the CPB tubing system is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive hemodilution and induced coagulopathy. While this is routinely performed in neonates and small infants, the routine priming of CPB system with FFP has been questioned in several randomized prospective studies in older infants. However, the results of these studies are conflicting. Moreover, they show methodological issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Frozen Plasma | Active comparator | Procedure: Surgery with CPB, Other: Fresh Frozen PlasmaThe priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells. |
| Plasmalyte | Active comparator | Procedure: Surgery with CPB, Other: PlasmalyteThe priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells. |
Who may qualify
- Ages
- 2 to 70 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB
Key exclusion criteria (4 listed)
- Patients with preoperative coagulation abnormalities
- Parental refusal
- Emergency surgery
- Patients with preoperative renal or hepatic dysfunction
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 |
|---|---|---|
| Surgery with CPB | Procedure or surgery | Fresh Frozen Plasma, Plasmalyte |
| Fresh Frozen Plasma | Other | Fresh Frozen Plasma |
| Plasmalyte | Other | Plasmalyte |
Primary outcome
Postoperative bleeding (mL blood in the chest tubes). Significant postoperative bleeding is defined as a bleeding of > 5ml/kg/h in the first 6hours postoperatively.
Time frame: The first 6 hours postoperatively
The exact amount of blood loss in the postoperative period per kilogram weight of child.
Increased risk of of donor exposure intraoperatively and postoperatively.
Time frame: The first 6 hours postoperatively
The total number of different packs of allogeneic blood products administered per child.
2 secondary outcomes
Volume of transfused allogenic blood products (mL).
Time frame: The first 6 hours postoperatively
Comparison of Rotem and Multiplate between both groups.
Time frame: The first 6 hours postoperatively
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 5 Dec 2018.
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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.
Mona Momeni, MD,PhD principal investigator
Université Catholique de Louvain; Cliniques Universitaires Saint Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with CPB, Fresh Frozen Plasma and Plasmalyte in people with Congenital Heart Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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: finished, as of the sponsor's last update on 5 Dec 2018. 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 Belgium. 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?
Postoperative bleeding (mL blood in the chest tubes). Significant postoperative bleeding is defined as a bleeding of > 5ml/kg/h in the first 6hours postoperatively. (time frame: The first 6 hours postoperatively). The study lists 2 primary outcomes in all. 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 5 Dec 2018.