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

NCT02567786 | Completed

• 1 other identifier: Plasma versus Plasmalyte
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The first 6 hours postoperatively

Secondary Outcomes (2)

• Volume of transfused allogenic blood products (mL).

  The first 6 hours postoperatively

• Comparison of Rotem and Multiplate between both groups.

  The first 6 hours postoperatively

Study Arms (2)

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.

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.

Procedure: Surgery with CPB; Other: Plasmalyte

Interventions

Surgery with CPB PROCEDURE

Fresh Frozen Plasma; Plasmalyte

Fresh Frozen Plasma OTHER

Fresh Frozen Plasma

Plasmalyte OTHER

Plasmalyte

Eligibility Criteria

• Age: 2 Months - 70 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Mona Momeni

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Surgical Procedures, Operative; Plasmalyte A

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mona Momeni, MD,PhD

  Université Catholique de Louvain; Cliniques Universitaires Saint Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: July 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

BE (1)