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Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children

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ClinicalTrials.gov Identifier: NCT02567786
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mona Momeni, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Procedure: Surgery with CPB Other: Fresh Frozen Plasma Other: Plasmalyte Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fresh Frozen Plasma
The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.
Procedure: Surgery with CPB
Other: Fresh Frozen Plasma
Active Comparator: Plasmalyte
The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.
Procedure: Surgery with CPB
Other: Plasmalyte



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Volume of transfused allogenic blood products (mL). [ Time Frame: The first 6 hours postoperatively ]
    The total volume of allogeneic blood products per kilogram weight of child.

  2. Comparison of Rotem and Multiplate between both groups. [ Time Frame: The first 6 hours postoperatively ]
    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.



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Ages Eligible for Study:   2 Months to 70 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB

Exclusion Criteria:

  • Patients with preoperative coagulation abnormalities
  • Parental refusal
  • Emergency surgery
  • Patients with preoperative renal or hepatic dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567786


Locations
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Belgium
Mona Momeni
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Mona Momeni, MD,PhD Université Catholique de Louvain; Cliniques Universitaires Saint Luc

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Responsible Party: Mona Momeni, MD, PhD, Clinical Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02567786     History of Changes
Other Study ID Numbers: Plasma versus Plasmalyte
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions