In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)

Emory University36 enrolled

Overview

This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for managing coagulopathies in neonates.

This study is a prospective, randomized control trial comparing two different sources of fibrinogen on clot kinetics (degradation and structure) in post-CPB coagulopathy in neonates undergoing cardiac surgery. The two sources of fibrinogen include the blood product, cryoprecipitate, and a blood product alternative, fibrinogen concentrate. Cryoprecipitate is an allogenic blood product that requires cross-matching and thawing prior to administration and is associated with immunologic reactions and possible pathogen transmission. Fibrinogen concentrate, a blood product alternative, is a purified form of fibrinogen, which undergoes a pasteurization process to minimize the risk of immunologic and allergic reactions. The primary aim of this study is compare the in vivo effect of post-CPB administration of FC, a blood product alternative, to cryoprecipitate on neonatal clot properties and clinical outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hemostasis

Interventions

Fibrinogen Concentrate (FC)DRUG

The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.

CryoprecipitateDRUG

The standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL.

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 Days

Medical Language ↔ Plain English

Inclusion Criteria: 1. Full term neonates (36-42 weeks gestational age) 2. Infants =\< 30 days of age at time of surgery 3. APGAR score of 6 or greater at 5 minutes after delivery 4. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta 5. Parents willing to participate and able to understand and sign the provided informed consent Exclusion Criteria: 1. Preterm neonates (less than 36 weeks gestation) 2. Patients undergoing an emergent procedure or surgery not requiring CPB 3. Patients with personal or family history of a coagulation defect or coagulopathy 4. Parents unwilling to participate or unable to understand and sign the provided informed consent

Locations (1)

Children's Healthcare of Atlanta (CHOA), Egleston

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Clot Degradation at 24 Hours Post-operatively

Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery.

Time frame: From induction of anesthesia to 24 hours postoperatively

Secondary Outcomes

Clot Strength

Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Strength will be assessed by rheology and atomic force microscopy (AFM).

Time frame: From induction of anesthesia to 24 hours postoperatively

Clot Polymerization Kinetic

Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Polymerization will be determined by thrombin-initiated turbidity/absorbency curves.

Time frame: From induction of anesthesia to 24 hours postoperatively

Fibrin Fiber Alignment

Clot structure is assessed by examination of images of clot fibrin fiber alignment. Quantification of clot fiber alignment was achieved through the application of an automated algorithm based on a fast Fourier transform that measures the alignment of the fibers, as well as visual inspection. A reference range has not been established for neonates, however, higher values indicate more dense clot structure.

Data from ClinicalTrials.gov

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