Reduced Anticoagulation Targets in Extracorporeal life support

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22774

Enrollment

330

Registered

2019-08-19

Start date

2020-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart or lungfailure

Interventions

Randomization between a target of 2-2.5x baseline aPTT (usual care, about 60-75 sec.), 1.5-2.0x (45-60 sec.) and therapeutic LMWH guided by weight and renal function.

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • ECLS treatment during the study period in one the participating centers • (deferred) informed consent • Age above 18

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Patients in whom the ECLS is only used to bridge a procedure like a high risk percutaneous coronary intervention or during surgery • No (deferred) informed consent • Vital indication for anticoagulation (e.g. mechanic mitral valve, pulmonary embolism) • Heparin induced thrombocytopenia (HIT)

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter is a composite endpoint consisting of: 1) severe hemorrhagic complications according to the ELSO definitions (see below); 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia, or acute pump failure; 3) mortality at 6 months. This composite outcome was designed to capture the net clinical effect of reduced anticoagulation targets, e.g. a reduction of major bleeding not counteracted by an increase in thromboembolic complications. Mortality is part of the composite outcome to capture unknown or unmeasured effects of reduced anticoagulation. Severe hemorrhagic complications will be registered according to the Extracorporeal Life Support Organization (ELSO) definitions for major bleeding and is defined as clinically overt bleeding with a decrease in hemoglobin of at least 1,24 mmol/L (2 g/dl)/24 hours, or a transfusion requirement of = 3 EH RBC over that same time period. Bleeding that is retroperitoneal, pulmonary or involves the central nervous system, or bleeding that requires surgical intervention is also considered major bleeding.	—

Measure

Time frame

The primary outcome parameter is a composite endpoint consisting of: 1) severe hemorrhagic complications according to the ELSO definitions (see below); 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia, or acute pump failure; 3) mortality at 6 months. This composite outcome was designed to capture the net clinical effect of reduced anticoagulation targets, e.g. a reduction of major bleeding not counteracted by an increase in thromboembolic complications. Mortality is part of the composite outcome to capture unknown or unmeasured effects of reduced anticoagulation. Severe hemorrhagic complications will be registered according to the Extracorporeal Life Support Organization (ELSO) definitions for major bleeding and is defined as clinically overt bleeding with a decrease in hemoglobin of at least 1,24 mmol/L (2 g/dl)/24 hours, or a transfusion requirement of = 3 EH RBC over that same time period. Bleeding that is retroperitoneal, pulmonary or involves the central nervous system, or bleeding that requires surgical intervention is also considered major bleeding.

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Secondary

Measure	Time frame
Secondary outcome parameters are: 1) blood transfusions; 2) quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator (ECMO); 4) vessel thrombosis after ECLS removal detected by echography (see below); 5) pulmonary embolism; 6) costs; 7) the individual components of the composite outcome; 8) all thromboembolic complications combined; and 9) all hemorrhagic complications combined.	—

Measure

Time frame

Secondary outcome parameters are: 1) blood transfusions; 2) quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator (ECMO); 4) vessel thrombosis after ECLS removal detected by echography (see below); 5) pulmonary embolism; 6) costs; 7) the individual components of the composite outcome; 8) all thromboembolic complications combined; and 9) all hemorrhagic complications combined.

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Contacts

Public ContactWalter van den Bergh

University Medical Center Groningen

w.m.van.den.bergh@umcg.nl050-3616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)