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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Intensity Anticoagulation | Experimental | 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. |
|
| Moderate Intensity Anticoagulation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity anticoagulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Bleeding Events | Major bleeding event, according to the International Society on Thrombosis and Hemostasis, defined as:
| From randomization to the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days. |
| Number of Participants With Thromboembolic Events | Thromboembolic event defined as:
| From randomization to the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 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 | 24-72 hours after decannulation |
| Number of Circuit or Circuit Component Exchanges |
| Measure | Description | Time Frame |
|---|---|---|
| Number of and Specific Reasons for "Missed" Enrollments | Reasons for "missed" enrollments (e.g. unavailability of research staff, refusal of clinical team to allow randomization, patient refusal of informed consent) | From ECMO cannulation to 24 hours after ECMO cannulation. |
| Duration of the Intervention Period (Days) |
Inclusion Criteria:
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:
Presence of a contraindication to anticoagulation:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D Casey, MD, MSc | Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15842354 | Background | Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x. | |
| 27714705 |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate-intensity Anticoagulation | Patients assigned to the moderate-intensity anticoagulation group received a continuous intravenous infusion of an anticoagulant targeting a goal aPTT of 40-60 seconds or a goal anti-Xa level of 0.2 to 0.3 IU/mL. The choice of anticoagulant (e.g., heparin or bivalirudin), monitoring strategy (e.g., partial thromboplastin time or anti-Xa level), frequency of monitoring, and protocol for titrating anticoagulation to achieve goals was determined by treating clinicians and institutional protocols. The protocols used to titrate continuous infusions of anticoagulation at each center are consistent with current recommendations and protocols for patients receiving venovenous ECMO in clinical care at other centers. |
| FG001 | Low-intensity Anticoagulation | Patients assigned to the low-intensity anticoagulation group received intermittent subcutaneous injections of an anticoagulant at a dose used for deep venous thromboembolism prophylaxis in critically ill patients. The choice of anticoagulant (e.g. heparin or enoxaparin) and the dose used for deep venous thromboembolism prophylaxis was determined by treating clinicians and institutional protocols. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Intensity Anticoagulation | Low intensity anticoagulation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Bleeding Events | Major bleeding event, according to the International Society on Thrombosis and Hemostasis, defined as:
| Posted | Count of Participants | Participants | From randomization to the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days. |
|
From randomization to the date of death or decannulation, whichever came first, through study completion, up to 134 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate-intensity Anticoagulation | Patients assigned to the moderate-intensity anticoagulation group received a continuous intravenous infusion of an anticoagulant targeting a goal aPTT of 40-60 seconds or a goal anti-Xa level of 0.2 to 0.3 IU/mL. The choice of anticoagulant (e.g., heparin or bivalirudin), monitoring strategy (e.g., partial thromboplastin time or anti-Xa level), frequency of monitoring, and protocol for titrating anticoagulation to achieve goals was determined by treating clinicians and institutional protocols. The protocols used to titrate continuous infusions of anticoagulation at each center are consistent with current recommendations and protocols for patients receiving venovenous ECMO in clinical care at other centers. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Whitney Gannon | Vanderbilt University Medical Center | 6109095789 | whitney.gannon@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2022 | Nov 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2023 | Nov 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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Single center, open-label, parallel-group, randomized pilot trial
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|
| Moderate Intensity Anticoagulation | Other | 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. |
|
Circuit or circuit component exchange during ECMO support |
| From randomization to the date of death or decannulation, whichever came first, through study completion, up to 134 days |
| New Heparin Induced Thrombocytopenia Diagnosis | New diagnosis of Heparin Induced Thrombocytopenia as measured by clinically obtained serotonin release assay | From randomization to the date of death or decannulation, whichever came first, through study completion, up to 134 days |
| Lowest Platelet Count | Lowest clinically obtained platelet count | From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days |
| Highest Total Bilirubin Values | Highest clinically obtained total bilirubin values | From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days |
| Highest Lactate Dehydrogenase Value | Highest clinically obtained lactate dehydrogenase value | From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days |
| Death Attributable to a Major Bleeding Event | In-hospital mortality attributable to a major bleeding event | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
| Death Attributable to a Thromboembolic Event | In-hospital mortality attributable to a thromboembolic event | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
| Ventilator-free Days | Number of days alive and free from mechanical ventilation between randomization and day 28. | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
| ICU Length of Stay | Number of days in the ICU following randomization. | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
| Hospital Length of Stay | Number of days in the hospital following randomization | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
| In-hospital Mortality | Death prior to hospital discharge | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
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) |
| From randomization to the first of decannulation or death, up to 134 days. |
| Background |
| Aubron C, DePuydt J, Belon F, Bailey M, Schmidt M, Sheldrake J, Murphy D, Scheinkestel C, Cooper DJ, Capellier G, Pellegrino V, Pilcher D, McQuilten Z. Predictive factors of bleeding events in adults undergoing extracorporeal membrane oxygenation. Ann Intensive Care. 2016 Dec;6(1):97. doi: 10.1186/s13613-016-0196-7. Epub 2016 Oct 6. |
| 23594433 | Background | Aubron C, Cheng AC, Pilcher D, Leong T, Magrin G, Cooper DJ, Scheinkestel C, Pellegrino V. Factors associated with outcomes of patients on extracorporeal membrane oxygenation support: a 5-year cohort study. Crit Care. 2013 Apr 18;17(2):R73. doi: 10.1186/cc12681. |
| 23944202 | Background | Zangrillo A, Landoni G, Biondi-Zoccai G, Greco M, Greco T, Frati G, Patroniti N, Antonelli M, Pesenti A, Pappalardo F. A meta-analysis of complications and mortality of extracorporeal membrane oxygenation. Crit Care Resusc. 2013 Sep;15(3):172-8. |
| 18434909 | Background | Combes A, Leprince P, Luyt CE, Bonnet N, Trouillet JL, Leger P, Pavie A, Chastre J. Outcomes and long-term quality-of-life of patients supported by extracorporeal membrane oxygenation for refractory cardiogenic shock. Crit Care Med. 2008 May;36(5):1404-11. doi: 10.1097/CCM.0b013e31816f7cf7. |
| 30642776 | Background | Munshi L, Walkey A, Goligher E, Pham T, Uleryk EM, Fan E. Venovenous extracorporeal membrane oxygenation for acute respiratory distress syndrome: a systematic review and meta-analysis. Lancet Respir Med. 2019 Feb;7(2):163-172. doi: 10.1016/S2213-2600(18)30452-1. Epub 2019 Jan 11. |
| 25595476 | Background | Murphy DA, Hockings LE, Andrews RK, Aubron C, Gardiner EE, Pellegrino VA, Davis AK. Extracorporeal membrane oxygenation-hemostatic complications. Transfus Med Rev. 2015 Apr;29(2):90-101. doi: 10.1016/j.tmrv.2014.12.001. Epub 2014 Dec 18. |
| 31959232 | Background | Chlebowski MM, Baltagi S, Carlson M, Levy JH, Spinella PC. Clinical controversies in anticoagulation monitoring and antithrombin supplementation for ECMO. Crit Care. 2020 Jan 20;24(1):19. doi: 10.1186/s13054-020-2726-9. |
| 25168949 | Background | Saini A, Spinella PC. Management of anticoagulation and hemostasis for pediatric extracorporeal membrane oxygenation. Clin Lab Med. 2014 Sep;34(3):655-73. doi: 10.1016/j.cll.2014.06.014. Epub 2014 Jul 24. |
| 30619862 | Background | Doyle AJ, Hunt BJ. Current Understanding of How Extracorporeal Membrane Oxygenators Activate Haemostasis and Other Blood Components. Front Med (Lausanne). 2018 Dec 12;5:352. doi: 10.3389/fmed.2018.00352. eCollection 2018. |
| 25565317 | Background | Tauber H, Ott H, Streif W, Weigel G, Loacker L, Fritz J, Heinz A, Velik-Salchner C. Extracorporeal membrane oxygenation induces short-term loss of high-molecular-weight von Willebrand factor multimers. Anesth Analg. 2015 Apr;120(4):730-6. doi: 10.1213/ANE.0000000000000554. |
| 10371130 | Background | Kasirajan V, Smedira NG, McCarthy JF, Casselman F, Boparai N, McCarthy PM. Risk factors for intracranial hemorrhage in adults on extracorporeal membrane oxygenation. Eur J Cardiothorac Surg. 1999 Apr;15(4):508-14. doi: 10.1016/s1010-7940(99)00061-5. |
| 28857905 | Background | Menaker J, Tabatabai A, Rector R, Dolly K, Kufera J, Lee E, Kon Z, Sanchez P, Pham S, Herr DL, Mazzeffi M, Rabinowitz RP, O'Connor JV, Stein DM, Scalea TM. Incidence of Cannula-Associated Deep Vein Thrombosis After Veno-Venous Extracorporeal Membrane Oxygenation. ASAIO J. 2017 Sep/Oct;63(5):588-591. doi: 10.1097/MAT.0000000000000539. |
| 26308437 | Background | Cooper E, Burns J, Retter A, Salt G, Camporota L, Meadows CI, Langrish CC, Wyncoll D, Glover G, Ioannou N, Daly K, Barrett NA. Prevalence of Venous Thrombosis Following Venovenous Extracorporeal Membrane Oxygenation in Patients With Severe Respiratory Failure. Crit Care Med. 2015 Dec;43(12):e581-4. doi: 10.1097/CCM.0000000000001277. |
| 28466601 | Background | Esper SA, Welsby IJ, Subramaniam K, John Wallisch W, Levy JH, Waters JH, Triulzi DJ, Hayanga JWA, Schears GJ. Adult extracorporeal membrane oxygenation: an international survey of transfusion and anticoagulation techniques. Vox Sang. 2017 Jul;112(5):443-452. doi: 10.1111/vox.12514. Epub 2017 May 3. |
| 27256966 | Background | Krueger K, Schmutz A, Zieger B, Kalbhenn J. Venovenous Extracorporeal Membrane Oxygenation With Prophylactic Subcutaneous Anticoagulation Only: An Observational Study in More Than 60 Patients. Artif Organs. 2017 Feb;41(2):186-192. doi: 10.1111/aor.12737. Epub 2016 Jun 3. |
| 31277018 | Background | Carter KT, Kutcher ME, Shake JG, Panos AL, Cochran RP, Creswell LL, Copeland H. Heparin-Sparing Anticoagulation Strategies Are Viable Options for Patients on Veno-Venous ECMO. J Surg Res. 2019 Nov;243:399-409. doi: 10.1016/j.jss.2019.05.050. Epub 2019 Jul 2. |
| 31563493 | Background | Wood KL, Ayers B, Gosev I, Kumar N, Melvin AL, Barrus B, Prasad S. Venoarterial-Extracorporeal Membrane Oxygenation Without Routine Systemic Anticoagulation Decreases Adverse Events. Ann Thorac Surg. 2020 May;109(5):1458-1466. doi: 10.1016/j.athoracsur.2019.08.040. Epub 2019 Sep 26. |
| 33627603 | Background | Olson SR, Murphree CR, Zonies D, Meyer AD, Mccarty OJT, Deloughery TG, Shatzel JJ. Thrombosis and Bleeding in Extracorporeal Membrane Oxygenation (ECMO) Without Anticoagulation: A Systematic Review. ASAIO J. 2021 Mar 1;67(3):290-296. doi: 10.1097/MAT.0000000000001230. |
| Background | ELSO. ELSO Anticoagulation Guidelines. 2014. |
| 23287906 | Background | 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. |
| 40081660 | Derived | Gannon WD, Pratt EH, Vogelsong MA, Adkisson WH, Bacchetta M, Bloom SL, Ford DJ, Guenthart BA, Landsperger JS, Qian ET, Rackley CR, Rice TW, Fielding-Singh V, Stokes JW, Stollings JL, Semler MW, Casey JD; Pragmatic Critical Care Research Group. Low-Intensity vs Moderate-Intensity Anticoagulation for Venovenous Extracorporeal Membrane Oxygenation: The Strategies for Anticoagulation During Venovenous Extracorporeal Membrane Oxygenation Pilot Trial. Chest. 2025 Sep;168(3):639-649. doi: 10.1016/j.chest.2025.02.032. Epub 2025 Mar 11. |
| BG001 | Moderate Intensity Anticoagulation | Moderate Intensity Anticoagulation: Participants 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Moderate Intensity Anticoagulation | 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. Moderate Intensity Anticoagulation: 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 | Number of Participants With Thromboembolic Events | Thromboembolic event defined as:
| Posted | Count of Participants | Participants | From randomization to the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days. |
|
|
|
| Secondary | Number of Participants With 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 | Posted | Count of Participants | Participants | 24-72 hours after decannulation |
|
|
|
|
| Secondary | Number of Circuit or Circuit Component Exchanges | Circuit or circuit component exchange during ECMO support | Posted | Number | Exchanges | From randomization to the date of death or decannulation, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | New Heparin Induced Thrombocytopenia Diagnosis | New diagnosis of Heparin Induced Thrombocytopenia as measured by clinically obtained serotonin release assay | Posted | Count of Participants | Participants | From randomization to the date of death or decannulation, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | Lowest Platelet Count | Lowest clinically obtained platelet count | Posted | Median | Inter-Quartile Range | cells per mcL | From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | Highest Total Bilirubin Values | Highest clinically obtained total bilirubin values | Posted | Median | Inter-Quartile Range | mg/dL | From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | Highest Lactate Dehydrogenase Value | Highest clinically obtained lactate dehydrogenase value | Posted | Median | Inter-Quartile Range | U/L | From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | Death Attributable to a Major Bleeding Event | In-hospital mortality attributable to a major bleeding event | Posted | Count of Participants | Participants | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | Death Attributable to a Thromboembolic Event | In-hospital mortality attributable to a thromboembolic event | Posted | Count of Participants | Participants | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | Ventilator-free Days | Number of days alive and free from mechanical ventilation between randomization and day 28. | Posted | Median | Inter-Quartile Range | days | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | ICU Length of Stay | Number of days in the ICU following randomization. | Posted | Median | Inter-Quartile Range | days | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | Hospital Length of Stay | Number of days in the hospital following randomization | Posted | Median | Inter-Quartile Range | days | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
|
|
|
| Secondary | In-hospital Mortality | Death prior to hospital discharge | Posted | Count of Participants | Participants | From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days |
|
|
|
| Other Pre-specified | Number of and Specific Reasons for "Missed" Enrollments | Reasons for "missed" enrollments (e.g. unavailability of research staff, refusal of clinical team to allow randomization, patient refusal of informed consent) | Posted | Count of Participants | Participants | From ECMO cannulation to 24 hours after ECMO cannulation. |
|
|
|
| Other Pre-specified | Duration of the Intervention Period (Days) | 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) | Posted | Median | Inter-Quartile Range | days | From randomization to the first of decannulation or death, up to 134 days. |
|
|
|
| 2 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Low-intensity Anticoagulation | Patients assigned to the low-intensity anticoagulation group received intermittent subcutaneous injections of an anticoagulant at a dose used for deep venous thromboembolism prophylaxis in critically ill patients. The choice of anticoagulant (e.g. heparin or enoxaparin) and the dose used for deep venous thromboembolism prophylaxis was determined by treating clinicians and institutional protocols. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
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| D002318 | Cardiovascular Diseases |