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

Recruiting

• Conditions: Extracorporeal Circulation; Complications; Extracorporeal Membrane Oxygenation Complication
• Interventions: Diagnostic Test: DIC markers and Thrombin Generation Parameters

• Registration Number: NCT06095518
• Lead Sponsor: Queen Mary Hospital, Hong Kong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Department of Intensive Care Unit, Tuen Mun Hospital	DIC markers and Thrombin Generation Parameters	-
Adult Intensive Care Unit, Queen Mary Hospital	DIC markers and Thrombin Generation Parameters	-

Primary Outcome Measures

Name	Time	Method
Composite of thrombotic and hemorrhagic events	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.

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong