Clinical trial NCT03965208: Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation
Official title: Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Extracorporeal Membrane Oxygenation Complication
Anticoagulants
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: Pacific University
First posted: 2019-05-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin.

Detailed description: The investigators will randomly assign 34 adult patients requiring ECMO to receive bivalirudin or unfractionated heparin in a 1:1 fashion. There will be 17 patients in each group for a total of 34 patients.

Unfractionated heparin binds to antithrombin thereby causing an anticoagulant effect while bivalirudin binds directly to thrombin. Use of unfractionated heparin in this population is problematic due to reliance on adequate levels of circulating antithrombin, complex pharmacokinetics, and variable clearance. Bivalirudin avoids many of these difficulties.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Require ECMO and systemic anticoagulation as determined by the primary treating physician
3. Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds

Exclusion Criteria:

1. Prior inclusion in this study
2. Patients with known or suspected heparin induced thrombocytopenia
3. Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
4. Allergy to heparin or related products or bivalirudin
5. Known anti-thrombin deficiency
6. Selection of a non-standard aPTT target range

Primary outcomes:
measure: Percentage of time in the target anticoagulation range
timeFrame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Secondary outcomes:
measure: Major bleeding events
timeFrame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
measure: Major clinical thrombotic events
timeFrame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
measure: Duration of oxygenator use
timeFrame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Other outcomes:
measure: Number of blood products received
timeFrame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
measure: Percentage of patients that reach the target anticoagulation range within the first 24 hours
timeFrame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Locations:
city: Portland
country: United States
facility: Legacy Health System
state: Oregon
Study officials:
affiliation: Pacific University
name: R Brigg Turner, PharmD
role: PRINCIPAL_INVESTIGATOR
References: