TEG Anticoagulation Monitoring During ECMO

NCT02271126 | Completed Phase 1

• 1 other identifier: 932/2014
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ECMO; Heparin; Thromboelastography; Bleeding complications

Outcome Measures

Primary Outcomes (2)

• Safety

  Safety will be addressed by monitoring the need of blood components, number of serious haemorrhagic events, thrombotic events and numbers of circuit replacement (due to circuit "activation" and characterized by a definite score that will be assessed daily).

  Two years

• Feasibility

  Heparin dose fluctuations and numbers of violation from the standardized protocol will be registered to assess feasibility.

  Two years

Study Arms (2)

TEG

EXPERIMENTAL

TEG-driven anticoagulation group: Anticoagulation will be monitored by TEG. Target will be a range of R parameter at Kaolin activated-TEG (R K-TEG) is 16 - 24 seconds; frequency of TEG assays may vary from a minimum of 3 times per day to a maximum of 6 depending on the standardized protocol. When TEG value falls well below the desired range an heparin bolus will be administered, when is too high infusion will be stopped for either 30 or 60 minutes.

Device: TEG monitoring; Drug: Heparin

APTT

ACTIVE COMPARATOR

APTT-driven anticoagulation group: anticoagulation will be monitored by aPTT. aPTT ratio target is 1.5 - 2.0 as for actual clinical practice; frequency of aPTT measurements may vary from a minimum of 3 times per day to a maximum of 6 depending on the standardized protocol. When aPTT value falls well below the desired range an heparin bolus will be administered. When too high, infusion will be stopped for either 30 or 60 minutes.

Device: APTT monitoring; Drug: Heparin

Interventions

TEG monitoring DEVICE

anticoagulation monitoring during ECMO will be according to TEG

Also known as: Thromboelastography

TEG

APTT monitoring DEVICE

anticoagulation monitoring during ECMO will be according to aPTT

Also known as: activated Partial Thromboplastin Time

APTT

Heparin DRUG

Anticoagulation provided to patients in ECMO

APTT; TEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients that initiate ECMO support for acute respiratory failure at our centre or by our equipe at another centre will be screened for eligibility.

You may not qualify if:

• Patients under the age of 18, with proven Heparin-induced Thrombocytopenia or with a platelets count of less than 30.000/mm3 will be excluded from the study.

Sponsors & Collaborators

• Policlinico Hospital: lead
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator

Study Sites (1)

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

Milan, Lombardy, 20131, Italy

Location

Related Publications (1)

• Panigada M, E Iapichino G, Brioni M, Panarello G, Protti A, Grasselli G, Occhipinti G, Novembrino C, Consonni D, Arcadipane A, Gattinoni L, Pesenti A. Thromboelastography-based anticoagulation management during extracorporeal membrane oxygenation: a safety and feasibility pilot study. Ann Intensive Care. 2018 Jan 16;8(1):7. doi: 10.1186/s13613-017-0352-8.

  PMID: 29340875 DERIVED

MeSH Terms

Interventions

Thrombelastography; Partial Thromboplastin Time; Heparin

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Mauro Panigada, MD

  Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 18, 2014
• First Posted: October 22, 2014
• Study Start: September 2, 2014
• Primary Completion: September 1, 2016
• Study Completion: November 30, 2016
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

IT (1)