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Fibrinogen Concentrate vs Cryoprecipitate

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ClinicalTrials.gov Identifier: NCT03014700
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Glyn David Williams, Stanford University

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.


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Biological: Fibrinogen Concentrate Biological: Cryoprecipitate Phase 4

Detailed Description:

Patients under 12 months of age requiring cardiopulmonary bypass surgery will be approached for the study. Patients with a pre- existing coagulopathy, including unexplained bleeding or history of clotting, will be excluded. Prior to the study beginning, patients will be randomized to our standard transfusion algorithm with cryoprecipitate or fibrinogen concentrate. As is standard of care, laboratory tests will be sent at standard times points

  1. after the induction of anesthesia,
  2. after initiation of bypass,
  3. after separation from bypass and administration of protamine, and transfusion of either fibrinogen concentrate or cryoprecipitate
  4. on arrival to the ICU. These laboratory tests include hematocrit, arterial blood gas, chemistry, thromboelastogram (TEG) and fibrinogen. Additional laboratory tests will be sent as indicated by the clinical scenario to determine transfusion requirements. For patients enrolled in the study, we will standardize the anesthetic management, cardiopulmonary bypass protocol, and transfusion thresholds in the operating room and ICU. We will collect demographic data, intraop and post-op laboratory values, bypass times, intraop and post op transfusion data, chest tube output, adverse events, and length of ventilation, ICU stay and hospital stay.

For patients randomized to the study arm (fibrinogen concentrate), the fibrinogen level measured on bypass will be used to calculate the appropriate dose of fibrinogen concentrate to achieve a level of 300mg/dL after separation from bypass. Fibrinogen concentrate will replace cryoprecipitate in our post-operative transfusion algorithm. If the patient has continued bleeding based on laboratory values and clinical situation, the patient will be given cryoprecipitate as a rescue measure. Patients not on the study protocol will receive our normal transfusion algorithm.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Repurposing of Fibrinogen Concentrate as a Cost-Effective and Safe Hemostatic Agent in Infants Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Actual Study Start Date : March 2016
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Fibrinogen

Arm Intervention/treatment
Active Comparator: Cryoprecipitate Arm
Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group
Biological: Cryoprecipitate
Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group

Active Comparator: Fibrinogen Concentrate Arm
Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group
Biological: Fibrinogen Concentrate
Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group




Primary Outcome Measures :
  1. Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival. [ Time Frame: From administration of the drug during surgery to ICU arrival postoperatively (up to 24 hours) ]
    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.


Secondary Outcome Measures :
  1. Chest Tube Output [ Time Frame: From administration end of surgery to 24 hours post operatively ]
    Volume of chest tube drainage evaluated over first 24 hours post operatively

  2. Hours of Mechanical Ventilation [ Time Frame: From administration of the drug during surgery to extubation in the ICU (up to 30 days) ]
  3. Length of Stay in Intensive Care Unit (ICU) [ Time Frame: From administration of the drug during surgery to discharge from the ICU (up to 3 months) ]
  4. Length of Stay in Hospital [ Time Frame: From administration of the drug during surgery to discharge from the hospital (up to 6 months) ]
  5. Count of Participants Who Died Within 30 Days Following Procedure [ Time Frame: From administration of the drug to 30 days following surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014700


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Georgia
Laura Downey
Emory, Georgia, United States, 30322
Sponsors and Collaborators
Stanford University
Emory University
Investigators
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Principal Investigator: Glyn D Williams, MBChB, FFA Stanford University
Principal Investigator: Laura Downey, MD Emory University
  Study Documents (Full-Text)

Documents provided by Glyn David Williams, Stanford University:
Study Protocol  [PDF] February 3, 2017
Statistical Analysis Plan  [PDF] March 8, 2019

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Responsible Party: Glyn David Williams, Professor, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03014700    
Other Study ID Numbers: 36374
First Posted: January 9, 2017    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases