Fibrinogen Concentrate vs Cryoprecipitate

NCT03014700 | Completed Phase 4 Results DMC

• 1 other identifier: 36374
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and allogenic blood transfusions. Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen concentrate will be as effective in treating post-CPB bleeding and will decrease total blood product exposure when used as part of a blood transfusion algorithm. We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a fibrinogen level \<250mg/dL while on bypass. We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard of care in the management of peri- operative bleeding in neonatal patients undergoing cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as effective as the standard of care, then we would plan a multi-center trial to demonstrate the safety and efficacy of this medication. If we are able to demonstrate that fibrinogen concentrate is effective, fibrinogen concentrate could replace allogenic products and potentially decrease transfusion related morbidity in mortality in this population.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival.

  For our study, 1 donor exposure = 1 unit of blood product transfusion. A blood product includes red blood cells, fresh frozen plasma, cryoprecipitate, and platelets.

  From administration of the drug during surgery to ICU arrival postoperatively (up to 24 hours)

Secondary Outcomes (5)

• Chest Tube Output

  From administration end of surgery to 24 hours post operatively

• Hours of Mechanical Ventilation

  From administration of the drug during surgery to extubation in the ICU (up to 30 days)

• Length of Stay in Intensive Care Unit (ICU)

  From administration of the drug during surgery to discharge from the ICU (up to 3 months)

• Length of Stay in Hospital

  From administration of the drug during surgery to discharge from the hospital (up to 6 months)

• Count of Participants Who Died Within 30 Days Following Procedure

  From administration of the drug to 30 days following surgery

Study Arms (2)

Cryoprecipitate Arm

ACTIVE COMPARATOR

Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group

Biological: Cryoprecipitate

Fibrinogen Concentrate Arm

ACTIVE COMPARATOR

Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group

Biological: Fibrinogen Concentrate

Interventions

Fibrinogen Concentrate BIOLOGICAL

Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group

Fibrinogen Concentrate Arm

Cryoprecipitate BIOLOGICAL

Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group

Cryoprecipitate Arm

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates of at least 32 weeks of gestational age and infants up to 12 months of age with the diagnosis of congenital heart disease, requiring open heart surgery with cardiopulmonary bypass

You may not qualify if:

• Pre-existing coagulopathy, including unexplained bleeding or history of clotting

Sponsors & Collaborators

• Stanford University: lead
• Emory University: collaborator

Study Sites (2)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Laura Downey

Emory, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Fibrinogen; cryoprecipitate coagulum

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Results Point of Contact

• Title: Glyn David Williams
• Organization: Stanford university School of Medicine

jumbo@stanford.edu

650-723-5728

Study Officials

• Glyn D Williams, MBChB, FFA

  Stanford University

  PRINCIPAL INVESTIGATOR

• Laura Downey, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: January 9, 2017
• Study Start: March 1, 2016
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)