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Human Fibrinogen Concentrate in Pediatric Cardiac Surgery (RiaSTAP)

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ClinicalTrials.gov Identifier: NCT02822599
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Tirotta, Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Brief Summary:
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.

Condition or disease Intervention/treatment Phase
Hypofibrinogenemia Afibrinogenemia Bleeding Disorders Drug: RiaStAP Drug: Saline Phase 4

Detailed Description:
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass. RiaSTAP will be administered after termination of Cardiopulmonary Bypass (CPB) at a dose of 70 mg/kg, in a prospective, randomized, controlled study. We hypothesize that the administration of RiaSTAP in this manner will reduce peri-operative bleeding and transfusion requirements.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Human Fibrinogen Concentrate (RiaSTAP) in Decreasing Blood Loss and the Need for Component Blood Therapy in Infants Undergoing Cardiopulmonary Bypass.
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Fibrinogen

Arm Intervention/treatment
Active Comparator: RiaSTAP
Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.
Drug: RiaStAP
To decrease post-operative bleeding volume.
Other Name: Fibrinogen Concentrate Human

Placebo Comparator: Saline
Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.
Drug: Saline
Placebo consisting of normal saline 0.9%
Other Name: Normal Saline 0.9%




Primary Outcome Measures :
  1. Patients suffering from postoperative bleeding after surgery [ Time Frame: 24 hours after surgery ]
    Primary efficacy endpoint to measure bleeding cc/kg, identity and total volume of transfused blood products


Secondary Outcome Measures :
  1. Post-Op End Points - Adverse Events [ Time Frame: 24 hours after surgery ]
    Patients requiring ventilator support, LOS in the CICU, re-exploration for bleeding, LOS in the hospital, monitoring of adverse events



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus Children's Hospital will be eligible for enrollment in the study.

Exclusion Criteria:

  • Patients who fall outside of the age range for the study will be excluded. Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM MCF > 15mm, will be excluded.

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): NCT02822599


Contacts
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Contact: Jenny Esteves, RRC 786-624-2854 jenny.esteves@nicklaushealth.org
Contact: Anabel Rodriguez, CCRC 786-624-2590 anabel.rodriguez@nicklaushealth.org

Locations
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United States, Florida
Nickalus Children's Hospital f/k/a Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Jenny Esteves, RRC    786-624-2854    jenny.esteves@nicklaushealth.org   
Contact: Anabel Rodriguez, CCRC    786-624-2590    anabel.rodriguez@nicklaushealth.org   
Principal Investigator: Christopher Tirotta, MD         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Christopher Tirotta, MD    305-666-6511    christopher.tirotta@nicklaushealth.org   
Contact: Anabel Rodriguez, CCRC    786-624-2590    anabel.rodriguez@nicklaushealth.org   
Sponsors and Collaborators
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Investigators
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Principal Investigator: Christopher Tirotta, MD Director Cardiac Anesthesia

Additional Information:
Publications:

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Responsible Party: Christopher Tirotta, Director Cardiac Anesthesia, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
ClinicalTrials.gov Identifier: NCT02822599     History of Changes
Other Study ID Numbers: NCH0000201496
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Christopher Tirotta, Nicklaus Children's Hospital f/k/a Miami Children's Hospital:
CBP, congenital heart defects, cardiopulmonary bypass

Additional relevant MeSH terms:
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Blood Coagulation Disorders
Hemostatic Disorders
Afibrinogenemia
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn