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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Surgery with CPB

Intervention Type PROCEDURE

Fresh Frozen Plasma

Intervention Type OTHER

Plasmalyte

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

Group Type ACTIVE_COMPARATOR

Surgery with CPB

Intervention Type PROCEDURE

Plasmalyte

Intervention Type OTHER

Interventions

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Surgery with CPB

Intervention Type PROCEDURE

Fresh Frozen Plasma

Intervention Type OTHER

Plasmalyte

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

70 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No