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
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Procedure: Surgery with CPB Other: Fresh Frozen Plasma Other: Plasmalyte||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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.
- 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.
- 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.
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
|Brussels, Belgium, 1200|
|Principal Investigator:||Mona Momeni, MD,PhD||Université Catholique de Louvain; Cliniques Universitaires Saint Luc|