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Trial record 30 of 988 for:    Heparin sodium

Bivalirudin vs Heparin in ECMO Patients

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ClinicalTrials.gov Identifier: NCT03707418
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.

Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Complication Drug: Heparin Sodium Drug: Bivalirudin Injection [Angiomax] Phase 1

Detailed Description:
This open label randomized study will compare the clinical outcomes of patients on ECMO who are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient time to randomize these frequently emergent patients. Consent for the study will be obtained from a legally authorized representative Prior to starting a continuous infusion of maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of cross-overs between the two research arms, circuit failures, decannulation, deaths and discharges from hospital.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Bivalirudin Injection (Angiomax)
This arm will receive intravenous Bivalirudin for ECMO anticoagulation for the extent of ECMO support or 7 days whichever comes first
Drug: Bivalirudin Injection [Angiomax]
Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels

Active Comparator: Heparin Sodium
This arm will receive intravenous Heparin Sodium for ECMO anticoagulation for the extent of ECMO support or 7 days whichever comes first
Drug: Heparin Sodium
Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels




Primary Outcome Measures :
  1. Number of heparin-induced thrombocytopenia (HIT) events [ Time Frame: 30 days ]
    This will be assessed by serum platelet factor 4 antibody level

  2. Number of Cross-overs between arms [ Time Frame: 30 days ]

    This will be assessed by number of cross over of patients from one arm to the other anti-coagulation arm for any particular clinical reason.

    Crossover patients will remain in the study and we will continue to collect protocol driven data. These patients will be analyzed separately from those with no cross-over.


  3. Number of circuit failures requiring a circuit exchange [ Time Frame: 30 days ]
    Will be determined by total number of circuit exchanges needed in ECMO circuit due to thrombosis. Circuit exchanges may be done due to lack of adequate gas exchange or increased resistance pre and post oxygenator >50mmHg, circuit thrombosis or failure requiring emergent decannulation

  4. Thrombotic events [ Time Frame: 30 days ]
    Collect number of thrombotic events, defined as any of the following events; embolic strokes, embolic end-organ ischemia, embolic ischemia to limbs, deep vein thrombosis or venous thromboembolism, Oxygenator effectiveness measured by resistance, Alveolar-arterial oxygen gradient and carbon dioxide elimination

  5. Bleeding events [ Time Frame: 30 days ]
    Will be assessed by the total number of one or more of the following: Chest tube output of blood, number of take-backs to operating room for bleeding, number of Hemorrhagic strokes, Gastrointestinal bleeding, Retroperitoneal hemorrhage, number of cessations of anticoagulation for refractory bleeding and any use of antifibrinolytics or factor VII

  6. Renal failure [ Time Frame: 30 days ]
    Defined as initiation of renal replacement therapy for kidney injury that develops on ECMO or increase in serum creatinine by more than 2 times its baseline or decrease in Glomerular Filtration Rate by more than 50% or urine output less than 0.3 mL/kg/hr. We will determine the number of patients with renal failure

  7. Number of Transfusions [ Time Frame: 30 days ]
    This will be assessed by any of the following: number of utilizations of packed red blood cells and utilization of fresh frozen plasma, utilization of platelets, utilization of cryoprecipitate, utilization of anti-thrombin III, utilization of factor VII, utilization of prothrombin complex concentrate

  8. Number of emergent decannulations [ Time Frame: 30 days ]
    This will be assessed by the number of times patient is separated from ECMO

  9. Number of patients surviving to discharge [ Time Frame: 30 days ]
    This will be assessed by the number of patients in each arm who survive to discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients on veno-arterial (VA) or veno-venous (VV)ECMO

Exclusion Criteria:

  • Patient or surrogate decision makers cannot provide informed consent.
  • Patients who have intolerance to either heparin or bivalirudin
  • Patients who received any form of thrombolytic therapy within the past 30 days.

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): NCT03707418


Contacts
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Contact: Judi Willhide, RN 410-955-3597 jwillhi3@jhmi.edu
Contact: Dan Choi, M.D. 410-955-2800 cchoi40@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Glenn Whitman, M.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03707418     History of Changes
Other Study ID Numbers: IRB00176475
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: No

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Bivalirudin
Hirudins
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors