DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study (DIC-ECMO)

July 21, 2025 updated by: Wincy Wing-Sze Ng, Queen Mary Hospital, Hong Kong
To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients requiring ECMO support

Description

Inclusion Criteria:

  • Age ≧ 18; AND
  • Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND
  • Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.

Exclusion Criteria:

  • Patients who are on central VA-ECMO support; OR
  • Patients with missing clinical data; OR
  • Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR
  • Post-operative admissions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult Intensive Care Unit, Queen Mary Hospital
Diagnostic test: DIC markers and Thrombin Generation Parameters
Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications
Department of Intensive Care Unit, Tuen Mun Hospital
Diagnostic test: DIC markers and Thrombin Generation Parameters
Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of thrombotic and hemorrhagic events
Time Frame: From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)

Thrombotic events include circuit-related thrombosis (e.g. oxygenator failure requiring circuit change) OR Non-circuit-related thrombosis (e.g. new pulmonary embolism or deep vein thrombosis while on ECMO.

Hemorrhagic events include bleeding at critical sites or requiring interventions.
From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary Hospital, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Actual)

April 7, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 23-259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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