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TEG Anticoagulation Monitoring During ECMO

NCT02271126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-07-05

No results posted yet for this study

Summary

The best anticoagulation strategy during Extracorporeal Membrane Oxygenation (ECMO) is unknown. Actual recommendations suggest to use unfractionated heparin infusion and monitor the effect with either activated Partial Thromboplastin Time (aPTT) or Activated Clotting Time (ACT). Since hemorrhage is still the major adverse effect of ECMO with impact on mortality and morbidity, the investigators raised a question whether an alternative monitoring technique namely Thromboelastography (TEG) could allow a more accurate management of anticoagulation in this setting. To test this hypothesis the investigators designed a pilot study to test safety and feasibility of an anticoagulation monitoring algorithm based on TEG versus aPTT.

Conditions

  • Extracorporeal Membrane Oxygenation Complication

Interventions

DEVICE

TEG monitoring

anticoagulation monitoring during ECMO will be according to TEG

DEVICE

APTT monitoring

anticoagulation monitoring during ECMO will be according to aPTT

DRUG

Heparin

Anticoagulation provided to patients in ECMO

Sponsors & Collaborators

  • The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

    collaborator OTHER

  • Policlinico Hospital

    lead OTHER

Principal Investigators

  • Mauro Panigada, MD · Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-02
Primary Completion
2016-09-30
Completion
2016-11-30

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 NCT02271126 on ClinicalTrials.gov