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

NCT06095518 | Recruiting

• 1 other identifier: UW 23-259
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.

Conditions

Extracorporeal Circulation; Complications; Extracorporeal Membrane Oxygenation Complication

Keywords

ECMO; Thrombosis; Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Composite of thrombotic and hemorrhagic events

  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)

Study Arms (2)

Adult Intensive Care Unit, Queen Mary Hospital

Diagnostic Test: DIC markers and Thrombin Generation Parameters

Department of Intensive Care Unit, Tuen Mun Hospital

Diagnostic Test: DIC markers and Thrombin Generation Parameters

Interventions

DIC markers and Thrombin Generation Parameters DIAGNOSTIC_TEST

Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications

Adult Intensive Care Unit, Queen Mary Hospital; Department of Intensive Care Unit, Tuen Mun Hospital

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring ECMO support

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wincy Ng

CONTACT

+852-22553111; wincyngwingsze@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Adult Intensive Care Unit

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 23, 2023
• Study Start: May 30, 2023
• Primary Completion: April 7, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-10

Locations

HK (1)