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Strategies for Anticoagulation During Venovenous ECMO (SAFE-ECMO)

Primary Purpose

Acute Hypoxemic Respiratory Failure, Anticoagulant-induced Bleeding, Thromboembolism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low intensity anticoagulation
Moderate Intensity Anticoagulation
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring ARDS, Hypoxemic respiratory failure, Extracorporeal Membrane Oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient receiving V-V ECMO
  2. Patient is located in a participating unit of the Vanderbilt University Medical Center (VUMC) adult hospital.

Exclusion Criteria:

  1. Patient is pregnant
  2. Patient is a prisoner
  3. Patient is < 18 years old
  4. Patient underwent ECMO cannulation greater than 24 hours prior to screening
  5. Presence of an indication for systemic anticoagulation:

    1. Ongoing receipt of systemic anticoagulation
    2. Planned administration of anticoagulation for an indication other than ECMO
    3. Presence of or plan to insert an arterial ECMO cannula
  6. Presence of a contraindication to anticoagulation:

    1. Active bleeding determined by treating clinicians to make anticoagulation unsafe
    2. Major surgery or trauma less than 72 hours prior to randomization
    3. Known history of a bleeding diathesis
    4. Ongoing severe thrombocytopenia (platelet count < 30,000)
    5. History of heparin-induced thrombocytopenia (HIT)
    6. Heparin allergy
  7. Positive SARS-CoV-2 test within prior 21 days or high clinical suspicion for COVID-19
  8. The treating clinician determines that the patient's risks of thromboembolism or bleeding necessitate a specific approach to anticoagulation management during V-V ECMO

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Intensity Anticoagulation

Moderate Intensity Anticoagulation

Arm Description

For patients assigned to the low intensity anticoagulation strategy, clinical teams will be instructed to initiate low intensity anticoagulation at doses and frequencies commonly used for deep vein thrombosis (DVT) prophylaxis. The choice of anticoagulant, dose, and frequency of administration will be deferred to treating clinicians.

For patients assigned to the moderate intensity anticoagulation group, clinical teams will be instructed to initiate a continuous infusion of moderate intensity anticoagulation targeting either a partial thromboplastin time (PTT) of 40-60 seconds or an Anti-Xa level of 0.2 to 0.3 IU/mL. The choice of anticoagulant and approach to dosing will be deferred to treating clinicians.

Outcomes

Primary Outcome Measures

Frequency of major bleeding events
Major bleeding event, according to the International Society on Thrombosis and Hemostasis, defined as: Fatal bleeding Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome Clinically overt bleeding associated with either a drop in hemoglobin level by at least 2.0 grams/dL or leading to transfusion of two or more units of packed red blood cells
Frequency of thromboembolic events
Thromboembolic event defined as: Deep venous thrombosis (DVT) Acute pulmonary embolism (PE) Intra-cardiac thrombosis Ischemic stroke Acute circuit thrombosis requiring urgent circuit exchange Acute arterial thromboembolism

Secondary Outcome Measures

Frequency of cannula-associated deep vein thrombosis
Cannula-associated deep vein thrombosis, as measured by four-extremity venous ultrasounds obtained 24-72 hours following decannulation among patients who were decannulation
Bleeding events per ECMO day
Number of major bleeding events per day of V-V ECMO
Thromboembolic events per ECMO day
Number of thromboembolic events per day of V-V ECMO
Bleeding events from randomization to the first of death or discharge
Number of bleeding events from date of randomization until the date of death or hospital discharge, whichever came first, up to 100 months
Thromboembolic events from randomization to the first of death or discharge
Number of thromboembolic events from randomization until the date of death or hospital discharge, whichever came first, up to 100 months
Frequency of circuit or circuit component exchanges
Circuit or circuit component exchange during ECMO support
ECMO circuit durability
The number of calendar days from randomization to death or decannulation divided by the Number of ECMO circuits used
Red blood cell transfusion volume per ECMO day
Total volume of packed red blood cells transfused from randomization to death or decannulation divided by the number of calendar days during this period
New Heparin Induced Thrombocytopenia diagnosis
New diagnosis of Heparin Induced Thrombocytopenia as measured by clinically obtained serotonin release assay
Lowest platelet count
Lowest clinically obtained platelet count
Highest total and indirect bilirubin values
Highest clinically obtained total and indirect bilirubin values
Highest lactate dehydrogenase value
Highest clinically obtained lactate dehydrogenase value
Death attributable to a major bleeding event
In-hospital mortality attributable to a major bleeding event
Death attributable to a thromboembolic event
In-hospital mortality attributable to a thromboembolic event
Ventilator-free days
Number of days alive and free from mechanical ventilation between randomization and day 28.
ICU-free days
Number of days alive and not in the ICU between randomization and day 28.
Hospital-free days
Number of days alive and not in the hospital between randomization and day 28.
In-hospital mortality
Death prior to hospital discharge

Full Information

First Posted
July 23, 2021
Last Updated
September 15, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04997265
Brief Title
Strategies for Anticoagulation During Venovenous ECMO
Acronym
SAFE-ECMO
Official Title
Strategies for Anticoagulation During Venovenous ECMO: The SAFE-ECMO Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
May 12, 2024 (Anticipated)
Study Completion Date
May 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications. As technology has improved, however, the incidence of thromboembolic events has decreased, leading to re-evaluation of the risks of anticoagulation, particularly during venovenous (V-V) ECMO. Recent data suggest that bleeding complications during V-V ECMO may be more strongly associated with mortality than thromboembolic complications, and case series have suggested that V-V ECMO can be safely performed without moderate or high intensity anticoagulation. At present, there is significant variability between institutions in the approach to anticoagulation during V-V ECMO. A definitive randomized controlled trial is needed to compare the effects of a low intensity fixed dose anticoagulation (low intensity) versus moderate intensity titrated dose anticoagulation (moderate intensity) on clinical outcomes during V-V ECMO. Before such a trial can be conducted, however, additional data are needed to inform the feasibility of the future trial.
Detailed Description
Since the inception of Extracorporeal Membrane Oxygenation (ECMO), moderate intensity titrated dose anticoagulation has been used to prevent clinically harmful thromboembolism and thrombotic mechanical complications. The impact of thromboembolic events on clinical outcomes during venovenous (V-V) extracorporeal membrane oxygenation (ECMO), however, is unclear, and complications related to bleeding are common and associated with increased morbidity and mortality. These findings have led many experts to suggest that anticoagulation strategies during V-V ECMO should be re-evaluated. Critical illness, in general, is associated with both coagulopathy and impaired hemostasis. These problems are compounded during ECMO by the artificial interface between blood and the non-biologic surface of the circuit components, which leads to activation of the coagulation system, consumptive thrombocytopenia, fibrinolysis, and thrombin generation. The sheer stress on blood components during ECMO also lead to destruction of high-molecular-weight von Willebrand multimers, interrupting primary hemostasis. Both bleeding and thromboembolism are common complications during ECMO. Bleeding events have been associated with poor clinical outcomes, likely mediated by an increased incidence of intracranial hemorrhage during ECMO. During intra-operative cardiopulmonary bypass and venoarterial (V-A) ECMO, ischemic strokes are a common and potentially deadly complication. During V-V ECMO, however, the majority of thromboembolic events are cannula-associated DVT and circuit thromboses requiring exchange, which are of unclear clinical significance. Various anticoagulation strategies have been proposed to balance the risks of bleeding and thromboembolism during V-V ECMO, including high intensity anticoagulation, moderate intensity anticoagulation, and low intensity anticoagulation (the equivalent of DVT prophylaxis). Observational studies have suggested that, compared to moderate intensity anticoagulation, low intensity anticoagulation reduces transfusion requirements without affecting the incidence of thrombosis, hemorrhage, or death. In one case series of 60 patients who were treated with only low-intensity subcutaneous heparin during V-V ECMO, rates of transfusions were lower than historical controls without any effect on the rate of thrombotic events. Similarly, a recent systematic review suggested that the rates of thromboembolism and circuit thrombosis among patients managed with a moderate intensity anticoagulation strategy during V-V ECMO were comparable to the rates reported among patients managed with a less intense anticoagulation strategy. To date, there are no randomized controlled trials comparing low intensity to moderate intensity anticoagulation during V-V ECMO. Guidelines from the Extracorporeal Life Support Organization (ELSO), the pre-eminent group for ECMO education and research, provide little guidance for the selection of anticoagulation strategy, and anticoagulation practices are highly variable across institutions. A large, multicenter, randomized trial is needed to determine the ideal strategy to anticoagulation during V-V ECMO. Before such a trial can be conducted, however, additional data are needed on the feasibility of randomizing patients to a specific anticoagulation strategy and study measurements. To facilitate a large, multicenter randomized controlled trial comparing low intensity anticoagulation to moderate intensity anticoagulation during V-V ECMO, a pilot trial is needed to establish feasibility and the performance of the primary outcome measures. Primary aim of the study: To demonstrate feasibility of a future large, multi-center randomized controlled trial comparing low intensity to moderate intensity anticoagulation among adults receiving V-V ECMO by demonstrating the ability to recruit and randomize participants, adhere to assigned anticoagulation strategy, and demonstrate adequate separation between groups in therapy delivered and intensity of anticoagulation achieved with the assigned anticoagulation strategies. Secondary aim of the study: To define and estimate the frequency of the primary efficacy, primary safety, and secondary outcomes of a future large, multi-center randomized controlled trial comparing low intensity vs moderate intensity anticoagulation among adults receiving V-V ECMO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure, Anticoagulant-induced Bleeding, Thromboembolism
Keywords
ARDS, Hypoxemic respiratory failure, Extracorporeal Membrane Oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, open-label, parallel-group, randomized pilot trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Intensity Anticoagulation
Arm Type
Experimental
Arm Description
For patients assigned to the low intensity anticoagulation strategy, clinical teams will be instructed to initiate low intensity anticoagulation at doses and frequencies commonly used for deep vein thrombosis (DVT) prophylaxis. The choice of anticoagulant, dose, and frequency of administration will be deferred to treating clinicians.
Arm Title
Moderate Intensity Anticoagulation
Arm Type
Active Comparator
Arm Description
For patients assigned to the moderate intensity anticoagulation group, clinical teams will be instructed to initiate a continuous infusion of moderate intensity anticoagulation targeting either a partial thromboplastin time (PTT) of 40-60 seconds or an Anti-Xa level of 0.2 to 0.3 IU/mL. The choice of anticoagulant and approach to dosing will be deferred to treating clinicians.
Intervention Type
Other
Intervention Name(s)
Low intensity anticoagulation
Intervention Description
Participants assigned to the low intensity anticoagulation strategy will receive anticoagulation at doses used for DVT prophylaxis in critically ill patients. The choice of agent (e.g. heparin or enoxaparin) and specific dosing will be at the discretion of the treating clinicians and will be prospectively recorded.
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Anticoagulation
Intervention Description
Patients assigned to the moderate intensity anticoagulation strategy will receive anticoagulation targeting a PTT goal of 40-60 seconds or anti-Xa level of 0.2 to 0.3 IU/mL. Choice of anticoagulant and monitoring strategy (PTT or anti-Xa level) will be at the discretion of the treating clinicians and will be prospectively recorded. Anticoagulant drips will be titrated according to institutional protocols. For patients who survive to decannulation, the infusion will be stopped one hour prior to decannulation. This approach to anticoagulation reflects the current approach for patients receiving V-V ECMO at Vanderbilt University Medical Center and is similar to protocols widely adopted for patients receiving V-V ECMO at other centers.
Primary Outcome Measure Information:
Title
Frequency of major bleeding events
Description
Major bleeding event, according to the International Society on Thrombosis and Hemostasis, defined as: Fatal bleeding Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome Clinically overt bleeding associated with either a drop in hemoglobin level by at least 2.0 grams/dL or leading to transfusion of two or more units of packed red blood cells
Time Frame
From randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Title
Frequency of thromboembolic events
Description
Thromboembolic event defined as: Deep venous thrombosis (DVT) Acute pulmonary embolism (PE) Intra-cardiac thrombosis Ischemic stroke Acute circuit thrombosis requiring urgent circuit exchange Acute arterial thromboembolism
Time Frame
From randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Secondary Outcome Measure Information:
Title
Frequency of cannula-associated deep vein thrombosis
Description
Cannula-associated deep vein thrombosis, as measured by four-extremity venous ultrasounds obtained 24-72 hours following decannulation among patients who were decannulation
Time Frame
24-48 hours after decannulation
Title
Bleeding events per ECMO day
Description
Number of major bleeding events per day of V-V ECMO
Time Frame
From from randomization to 24 hours after decannulation
Title
Thromboembolic events per ECMO day
Description
Number of thromboembolic events per day of V-V ECMO
Time Frame
From from randomization to 24 hours after decannulation
Title
Bleeding events from randomization to the first of death or discharge
Description
Number of bleeding events from date of randomization until the date of death or hospital discharge, whichever came first, up to 100 months
Time Frame
From date of randomization until the date of death or hospital discharge, whichever came first, through study completion, an average of 2 years.
Title
Thromboembolic events from randomization to the first of death or discharge
Description
Number of thromboembolic events from randomization until the date of death or hospital discharge, whichever came first, up to 100 months
Time Frame
From randomization until the date of death or hospital discharge, whichever came first, through study completion, an average of 2 years.
Title
Frequency of circuit or circuit component exchanges
Description
Circuit or circuit component exchange during ECMO support
Time Frame
From randomization to the date of death or decannulation, whichever came first, through study completion, an average of 2 years.
Title
ECMO circuit durability
Description
The number of calendar days from randomization to death or decannulation divided by the Number of ECMO circuits used
Time Frame
From randomization to the date of death or decannulation, whichever came first, through study completion, an average of 2 years.
Title
Red blood cell transfusion volume per ECMO day
Description
Total volume of packed red blood cells transfused from randomization to death or decannulation divided by the number of calendar days during this period
Time Frame
From randomization to the date of death or decannulation, whichever came first, through study completion, an average of 2 years.
Title
New Heparin Induced Thrombocytopenia diagnosis
Description
New diagnosis of Heparin Induced Thrombocytopenia as measured by clinically obtained serotonin release assay
Time Frame
From randomization to the date of death or decannulation, whichever came first, through study completion, an average of 2 years.
Title
Lowest platelet count
Description
Lowest clinically obtained platelet count
Time Frame
From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Title
Highest total and indirect bilirubin values
Description
Highest clinically obtained total and indirect bilirubin values
Time Frame
From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Title
Highest lactate dehydrogenase value
Description
Highest clinically obtained lactate dehydrogenase value
Time Frame
From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Title
Death attributable to a major bleeding event
Description
In-hospital mortality attributable to a major bleeding event
Time Frame
From randomization to the date of death or discharge, whichever came first, through study completion, an average of 2 years.
Title
Death attributable to a thromboembolic event
Description
In-hospital mortality attributable to a thromboembolic event
Time Frame
From randomization to the date of death or discharge, whichever came first, through study completion, an average of 2 years.
Title
Ventilator-free days
Description
Number of days alive and free from mechanical ventilation between randomization and day 28.
Time Frame
From randomization to the date of death or discharge, whichever came first, through study completion, an average of 2 years.
Title
ICU-free days
Description
Number of days alive and not in the ICU between randomization and day 28.
Time Frame
From randomization to the date of death or discharge, whichever came first, through study completion, an average of 2 years.
Title
Hospital-free days
Description
Number of days alive and not in the hospital between randomization and day 28.
Time Frame
From randomization to the date of death or discharge, whichever came first, through study completion, an average of 2 years.
Title
In-hospital mortality
Description
Death prior to hospital discharge
Time Frame
From randomization to the date of death or discharge, whichever came first, through study completion, an average of 2 years.
Other Pre-specified Outcome Measures:
Title
Number of patients screened per month
Description
Number of patients screened for study enrollment per month
Time Frame
Through study completion, an average of 2 years.
Title
Number of patients eligible for the study
Description
Number of patients who are eligible for the study per month
Time Frame
Through study completion, an average of 2 years.
Title
Number of and the specific exclusion criteria met
Description
The specific exclusion criteria met (for any patient ineligible for enrollment)
Time Frame
Through study completion, an average of 2 years.
Title
Number of and specific reasons for "missed" enrollments
Description
Reasons for "missed" enrollments (e.g. unavailability of research staff, refusal of clinical team to allow randomization, patient refusal of informed consent)
Time Frame
Through study completion, an average of 2 years.
Title
Number of patients enrolled per month
Description
Number of patients enrolled in the study per month
Time Frame
Through study completion, an average of 2 years.
Title
Proportion of patients adhering to randomized assignment
Description
Adherence to the assigned anticoagulation strategy will be adequate if more than 80% of patients have fewer than 10% of monitored values as major protocol violations.
Time Frame
Through study completion, an average of 2 years.
Title
Hours receiving low intensity or moderate intensity anticoagulation
Description
Hours receiving low intensity or moderate intensity anticoagulation per day
Time Frame
Through study completion, an average of 2 years.
Title
Time from ECMO cannulation to randomization (hours)
Description
Time from ECMO cannulation to randomization in hours
Time Frame
Through study completion, an average of 2 years.
Title
Duration of the intervention period (days)
Description
Duration of the intervention period, defined as the time from randomization to the first of: diagnosis of a major bleeding event, diagnosis of a thromboembolic event, placement of an arterial ECMO cannula, decannulation from ECMO, or death (days)
Time Frame
Through study completion, an average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient receiving V-V ECMO Patient is located in a participating unit of the Vanderbilt University Medical Center (VUMC) adult hospital. Exclusion Criteria: Patient is pregnant Patient is a prisoner Patient is < 18 years old Patient underwent ECMO cannulation greater than 24 hours prior to screening Presence of an indication for systemic anticoagulation: Ongoing receipt of systemic anticoagulation Planned administration of anticoagulation for an indication other than ECMO Presence of or plan to insert an arterial ECMO cannula Presence of a contraindication to anticoagulation: Active bleeding determined by treating clinicians to make anticoagulation unsafe Major surgery or trauma less than 72 hours prior to randomization Known history of a bleeding diathesis Ongoing severe thrombocytopenia (platelet count < 30,000) History of heparin-induced thrombocytopenia (HIT) Heparin allergy Positive SARS-CoV-2 test within prior 21 days or high clinical suspicion for COVID-19 The treating clinician determines that the patient's risks of thromboembolism or bleeding necessitate a specific approach to anticoagulation management during V-V ECMO
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Whitney D Gannon, MSN, MS
Phone
6109095789
Email
whitney.gannon@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan D Casey, MD, MSc
Phone
502-645-0153
Email
jonathan.d.casey@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Casey, MD, MSc
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Whitney Gannon, MS
Phone
610-909-5789
Email
whitney.gannon@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Request will be reviewed by the study team and approval will be contingent upon the execution of a data use agreement.
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23287906
Citation
Bembea MM, Annich G, Rycus P, Oldenburg G, Berkowitz I, Pronovost P. Variability in anticoagulation management of patients on extracorporeal membrane oxygenation: an international survey. Pediatr Crit Care Med. 2013 Feb;14(2):e77-84. doi: 10.1097/PCC.0b013e31827127e4.
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Strategies for Anticoagulation During Venovenous ECMO

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