Bivalirudin vs Heparin in ECMO Patients

NCT03707418 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: IRB00176475
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation Complication

Outcome Measures

Primary Outcomes (9)

• Number of heparin-induced thrombocytopenia (HIT) events

  This will be assessed by serum platelet factor 4 antibody level

  30 days

• Number of Cross-overs between arms

  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.

  30 days

• Number of circuit failures requiring a circuit exchange

  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

  30 days

• Thrombotic events

  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

  30 days

• Bleeding events

  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

  30 days

• Renal failure

  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

  30 days

• Number of Transfusions

  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

  30 days

• Number of emergent decannulations

  This will be assessed by the number of times patient is separated from ECMO

  30 days

• Number of patients surviving to discharge

  This will be assessed by the number of patients in each arm who survive to discharge

  30 days

Study Arms (2)

Bivalirudin Injection (Angiomax)

ACTIVE COMPARATOR

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]

Heparin Sodium

ACTIVE COMPARATOR

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

Interventions

Heparin Sodium DRUG

Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels

Heparin Sodium

Bivalirudin Injection [Angiomax] DRUG

Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels

Bivalirudin Injection (Angiomax)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Hasegawa D, Sato R, Prasitlumkum N, Nishida K, Keaton B, Acquah SO, Im Lee Y. Comparison of Bivalirudin Versus Heparin for Anticoagulation During Extracorporeal Membrane Oxygenation. ASAIO J. 2023 Apr 1;69(4):396-401. doi: 10.1097/MAT.0000000000001814. Epub 2022 Apr 10.

  PMID: 36194483 DERIVED

MeSH Terms

Interventions

Heparin; bivalirudin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Glenn Whitman, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 19, 2021

Record last verified: 2020-04

Locations

US (1)