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Antithrombin Supplementation in ECMO

NCT03208270 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-05-17

No results posted yet for this study

Summary

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.

Conditions

  • Extracorporeal Membrane Oxygenation

Interventions

DRUG

Antithrombin supplementation

antithrombin concentrate will be supplemented to maintain a functional antithrombin level between 80%-120%

DRUG

No antithrombin supplementation

supplementation of antithrombin will not be provided unless "heparin resistance" occurs

Sponsors & Collaborators

  • The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

    collaborator OTHER

  • Policlinico Hospital

    lead OTHER

Principal Investigators

  • Mauro Panigada, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2019-05-15
Completion
2019-05-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03208270 on ClinicalTrials.gov