Extracorporeal Membrane Oxygenation Clinical Trial
Official title:
Pilot Study of Antithrombin Supplementation During Extracorporeal Membrane Oxigenation
Verified date | May 2019 |
Source | Policlinico Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | May 15, 2019 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients requiring veno-venous ECMO for severe respiratory failure. Exclusion Criteria: - patients with pre-existent heparin-induced thrombocytopenia |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
Policlinico Hospital | The Mediterranean Institute for Transplantation and Advanced Specialized Therapies |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of heparin | Heparin dosage to maintain aPTT ratio between 1.5-2 | through study completion, an average of 10 days | |
Secondary | Bleeding | Bleeding complications | through study completion, an average of 10 days | |
Secondary | Adequacy of anticoagulation | Adequacy of anticoagulation, assessed through Anti-Xa levels | through study completion, an average of 10 days | |
Secondary | thrombosis | Patient's or circuit thrombosis | through study completion, an average of 10 days | |
Secondary | transfusions | Blood products transfusion requirements | through study completion, an average of 10 days |
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