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OpenTrials
Completed

NCT Number: NCT02567786

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

2 month–70 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mona Momeni

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery with CPB

Procedure

Fresh Frozen Plasma

Other

plasmalyte

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2015
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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