Extracorporeal Membrane Oxygenation Clinical Trial
Official title:
Pilot Study of Antithrombin Supplementation During Extracorporeal Membrane Oxigenation
Bleeding is the most feared complication during extracorporeal membrane oxygenation (ECMO) and is associated with high dosing of heparin. There is no consensus on antithrombin (AT) supplementation during ECMO. However, AT is needed by heparin to properly anticoagulate. We hypothesize that maintaining normal antithrombin levels during ECMO is associated with a less heparin dosing and more adequate level of anticoagulation.
Extracorporeal membrane oxygenation (ECMO) is a life support for patients with severe acute
respiratory failure when conventional treatments failed but it is accompanied by a
significant risk of bleeding. Heparin is required during ECMO to avoid circuit thrombosis and
its anticoagulant effect is strictly dependent on antithrombin (AT). AT also plays a central
role in mediating inflammation. Acquired AT deficiency is common in patients on ECMO,
arguably due to long term anticoagulation in addition to sepsis itself. Guidelines suggest to
supplement AT in ECMO only when its deficiency coexists with heparin resistance. Few studies
evaluated the effect of AT supplementation during ECMO without a consensus on the appropriate
level to be maintained. AT supplementation increase anti-Factor Xa (anti-Xa) levels without
increasing heparin dosage. This may have a clinical impact because risk of bleeding during
ECMO is associated with higher heparin dosage.
We hypothesize that maintaining normal antithrombin activity levels (80%-120%) during ECMO is
associated with: I. less heparin dosage, II. a more adequate level of anticoagulation, III.
less hemostasis related complications, and IV. a lower level of inflammation.
Adult patients on veno-venous ECMO for respiratory failure will be randomized to maintain AT
between 80% and 100% (study group) or no supplementation unless heparin resistance occurs
(control group). Sample size of at least 20 patients per group (n=40) is calculated upon the
primary outcome measure of reduction of heparin use in the study group compared to the
control group. AT and anti-Xa will be measured before ECMO and daily while on ECMO.
Anticoagulation will be guaranteed with unfractionated heparin infusion with a target aPTT
1.5-2X normal. Study will end at ECMO removal.
Consistent literature suggests that current ECMO anticoagulation strategies are suboptimal
probably due to improper antithrombin supplementation. A normal antithrombin level could
guarantee an adequate anticoagulation regimen.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03685383 -
Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
|
N/A | |
Not yet recruiting |
NCT05106491 -
Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
|
N/A | |
Recruiting |
NCT05699005 -
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
|
Phase 1 | |
Recruiting |
NCT05444764 -
PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
|
||
Completed |
NCT05038943 -
Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation
|
N/A | |
Not yet recruiting |
NCT05341687 -
Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
|
||
Suspended |
NCT04385771 -
Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation
|
N/A | |
Recruiting |
NCT03766282 -
Pharmacokinetics in Extracorporeal Membrane Oxygenation
|
||
Completed |
NCT03355625 -
Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
|
||
Completed |
NCT01521195 -
Oxygen Consumption In Critically Ill Children
|
N/A | |
Recruiting |
NCT04620070 -
ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest
|
N/A | |
Recruiting |
NCT06062212 -
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
|
||
Recruiting |
NCT05730114 -
Monitoring Antiplatelet Drugs in Cardiac Arrest Patients
|
||
Completed |
NCT05154071 -
Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality
|
||
Recruiting |
NCT04536272 -
Reduced Anticoagulation Targets in ECLS (RATE)
|
Phase 3 | |
Completed |
NCT05693051 -
Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
|
||
Completed |
NCT03764319 -
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
|
N/A | |
Recruiting |
NCT05762029 -
Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
|
||
Completed |
NCT02995811 -
Characterising Changes in Muscle Quantity and Quality in Patients Requiring ECMO Oxygen During Critical Illness
|
||
Recruiting |
NCT04754854 -
Reduction of Blood Recirculation in Veno-Venous ECMO
|