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

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Surgery with CPB
Fresh Frozen Plasma
Plasmalyte
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

2 Months - 70 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mona Momeni

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fresh Frozen Plasma

Plasmalyte

Arm Description

The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.

The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.

Outcomes

Primary Outcome Measures

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.
Increased risk of of donor exposure intraoperatively and postoperatively.
The total number of different packs of allogeneic blood products administered per child.

Secondary Outcome Measures

Volume of transfused allogenic blood products (mL).
The total volume of allogeneic blood products per kilogram weight of child.
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.

Full Information

First Posted
September 29, 2015
Last Updated
December 4, 2018
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02567786
Brief Title
Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fresh Frozen Plasma
Arm Type
Active Comparator
Arm Description
The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.
Arm Title
Plasmalyte
Arm Type
Active Comparator
Arm Description
The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.
Intervention Type
Procedure
Intervention Name(s)
Surgery with CPB
Intervention Type
Other
Intervention Name(s)
Fresh Frozen Plasma
Intervention Type
Other
Intervention Name(s)
Plasmalyte
Primary Outcome Measure Information:
Title
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.
Description
The exact amount of blood loss in the postoperative period per kilogram weight of child.
Time Frame
The first 6 hours postoperatively
Title
Increased risk of of donor exposure intraoperatively and postoperatively.
Description
The total number of different packs of allogeneic blood products administered per child.
Time Frame
The first 6 hours postoperatively
Secondary Outcome Measure Information:
Title
Volume of transfused allogenic blood products (mL).
Description
The total volume of allogeneic blood products per kilogram weight of child.
Time Frame
The first 6 hours postoperatively
Title
Comparison of Rotem and Multiplate between both groups.
Description
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.
Time Frame
The first 6 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
70 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Momeni, MD,PhD
Organizational Affiliation
Université Catholique de Louvain; Cliniques Universitaires Saint Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mona Momeni
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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

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