A Phase 2/3 interventional study of Antithrombin supplementation and No antithrombin supplementation in Extracorporeal Membrane Oxygenation, sponsored by Policlinico Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-17.
Sponsored by Policlinico Hospital · Phase 2/3, Interventional, and Other
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.
Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to the study group will receive supplementation of antithrombin concentrate to maintain a functional antithrombin level between 80%-120%.
Drug: Antithrombin supplementation
Patients randomized to the control group will never receive supplementation of antithrombin unless "heparin resistance" occurs.
Drug: No antithrombin supplementation
antithrombin concentrate will be supplemented to maintain a functional antithrombin level between 80%-120%
Also known as: Antithtrombin
supplementation of antithrombin will not be provided unless "heparin resistance" occurs
Also known as: No antithrombin
Amount of heparin
Heparin dosage to maintain aPTT ratio between 1.5-2
Time frame: through study completion, an average of 10 days
Bleeding
Bleeding complications
Time frame: through study completion, an average of 10 days
Adequacy of anticoagulation
Adequacy of anticoagulation, assessed through Anti-Xa levels
Time frame: through study completion, an average of 10 days
thrombosis
Patient's or circuit thrombosis
Time frame: through study completion, an average of 10 days
transfusions
Blood products transfusion requirements
Time frame: through study completion, an average of 10 days
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Policlinico Hospital