Clinical trial NCT03932240: In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Official title: In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemostasis
Keywords: Fibrinogen Concentrate
FC
Cryoprecipitate
Transfusion
in vivo
Open-heart surgery
Cardiopulmonary Bypass
Fibrin Network Structure
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clot Degradation at 24 Hours Post-operatively
timeFrame: From induction of anesthesia to 24 hours postoperatively
Secondary outcomes:
measure: Clot Strength
timeFrame: From induction of anesthesia to 24 hours postoperatively
measure: Clot Polymerization Kinetic
timeFrame: From induction of anesthesia to 24 hours postoperatively
measure: Fibrin Fiber Alignment
timeFrame: From induction of anesthesia to 24 hours postoperatively
measure: Interoperative Transfusion Requirement
timeFrame: During surgery (up to 6 hours)
measure: Transfusion Requirements Within the First 24 Hours After Surgery
timeFrame: 24 hours postoperatively
measure: Amount of Post-operative Bleeding
timeFrame: Up to 24 hours postoperatively
measure: Mechanical Ventilation Time
timeFrame: Time of extubation (up to 2 weeks)
measure: Length of ICU Stay
timeFrame: At discharge from ICU (typically up to 21 days)
measure: Length of Hospital Stay
timeFrame: At discharge from hospital (up to 150 days)
measure: Number of Adverse Events
timeFrame: Within seven days of surgery
Other outcomes:
measure: Number of Events of Postoperative Thrombosis
timeFrame: Within the first 24 hours of surgery
measure: Fibrinogen Plasma Level
timeFrame: From induction of anesthesia to 24 hours postoperatively
measure: Thrombin Plasma Level
timeFrame: From induction of anesthesia to 24 hours postoperatively
measure: FXIII Plasma Level
timeFrame: From induction of anesthesia to 24 hours postoperatively
measure: Von Willebrand Factor Plasma Level
timeFrame: From induction of anesthesia to 24 hours postoperatively
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta (CHOA), Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Laura Downey, MD
role: PRINCIPAL_INVESTIGATOR
References: