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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03932240

Recruitment Status Suspended (All subject enrollment/follow up is on hold due to COVID-19 pandemic)

First Posted April 30, 2019

Last update posted May 1, 2020

Study Description

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.

  • Condition or Disease:Hemostasis
  • Intervention/Treatment: Drug: Fibrinogen Concentrate (FC)
    Drug: Cryoprecipitate
  • Phase: Phase 3
Detailed Description

This study is a prospective, randomized control trial comparing two different sources of fibrinogen on clot kinetics (degradation time, structure, strength and polymerization) 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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 36 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Fibrinogen Concentrate (FC)
After separation from bypass, patients will receive platelets and FC. The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration. If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.
Drug: Fibrinogen Concentrate (FC)
The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.
Active Comparator: Cryoprecipitate
After separation from bypass, patients will receive platelets and cryoprecipitate. Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL. If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.
Drug: Cryoprecipitate
Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL
Outcome Measures
  • Primary Outcome Measures: 1. Change in clot degradation time [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. Clot degradation will be determined by degradation kinetic study.
  • Secondary Outcome Measures: 1. Change in clot strength [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. Strength will be assessed by rheology and atomic force microscopy (AFM).
  • 2. Change in clot polymerization kinetic [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. Polymerization will be determined by thrombin-initiated turbidity/absorbency curves.
  • 3. Change in in clot structure [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. Fiber alignment will be assessed using fast Fourier transform.
  • 4. Transfusion requirement intraoperatively [ Time Frame: During surgery (up to 6 hours) ]
    Transfusion requirement intraoperatively will be recorded.
  • 5. Transfusion requirements within the first 24 hours after surgery [ Time Frame: 24 hours postoperatively ]
    Transfusion requirements within the first 24 hours of surgery will be recorded.
  • 6. Amount of post-operative bleeding [ Time Frame: 24 hours postoperatively ]
    Post-operative bleeding will be recorded by 24 hour chest tube output
  • 7. Mechanical ventilation time [ Time Frame: 24 hours postoperatively ]
    Mechanical ventilation time will be recorded.
  • 8. Length of ICU stay. [ Time Frame: Up to 30 days ]
    Length of ICU stay will be recorded.
  • 9. Length of hospital stay. [ Time Frame: Up to 30 days ]
    Length of hospital stay will be recorded.
  • 10. Number of adverse events [ Time Frame: Within seven days of surgery ]
    Adverse events within seven days of surgery will be recorded.
  • Other Outcome Measures: 1. Number of events of postoperative thrombosis [ Time Frame: Within the first 24 hours of surgery ]
    Number of events of postoperative thrombosis will be recorded
  • 2. Change in fibrinogen plasma level [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. ELISA will be used to measure coagulation factors at each time point.
  • 3. Change in thrombin plasma level [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. ELISA will be used to measure coagulation factors at each time point.lot analysis.
  • 4. Change in FXIII plasma level [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. ELISA will be used to measure coagulation factors at each time point.lot analysis.
  • 5. Change in Willebrand Factor plasma level [ Time Frame: 1) within 2 hours of induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1hour of separation from bypass; 3) 24 hours post-operatively in the ICU ]
    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 -80oC and utilized for the clot analysis. ELISA will be used to measure coagulation factors at each time point.lot analysis.
Eligibility Criteria
  • Ages Eligible for Study: up to 30 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Full term neonates (36-42 weeks gestational age)

2. Infants =< 30 days of age 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

Contacts and Locations
Contacts
Locations

United States, Georgia
Children's Healthcare of Atlanta (CHOA), Egleston
Atlanta

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator: Laura Downey, MD Emory University

More Information
  • Responsible Party: Emory University
  • ClinicalTrials.gov Identifier: NCT03932240 History of Changes
  • Other Study ID Numbers: IRB00109310
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: May 1, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), will be shared.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF)
  • Time Frame: Beginning 3 months and ending 5 years following article publication.
  • Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved protocol. Proposals should be directed to laura.ansley.downey@emory.edu. To gain access, data requestors will need to sign and obtain a data use agreement. The data will be available for five years in the investigator's Emory's data warehouse.
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Emory University: in vivo
    Fibrinogen Concentrate
    Cryoprecipitate
    Transfusion
    Open-heart surgery
    Cardiopulmonary Bypass
    Fibrin Network Structure
    FC