The Use of Thrombin Generation Assay in Detection of Cent... | NCT06094387

Studies
The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients

NCT06094387

Sponsor

Queen Mary Hospital, Hong Kong

Status

Unknown status

Last Update Posted

Apr 9, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Central Line Complication
Thrombosis, Venous

Interventions

Thrombin generation assay

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2024Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

Oct 13, 2023

First Submission Date that Met QC Criteria

Oct 18, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2024

Last Update Posted Date

Apr 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Thrombin generation assay	Diagnostic Test	Thrombin generation parameters in patients receiving central catheter insertion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis	The primary outcome measure is the difference in peak thrombin generation (nM) between patients with and without central line related thrombosis	From the time of CVC insertion to the time of CVC removal

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≧ 18; AND
Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND
Clinically indicated for central catheter insertion, which includes central venous catheters and dialysis catheters; AND
Expected to have the central catheter in place for at least 5 days in their ICU stay.

Exclusion Criteria:

Patients known to have active venous thromboembolism including deep venous thrombosis or pulmonary embolism;
Patients known to have hypercoagulable states, e.g., hereditary thrombophilia, antiphospholipid syndrome; OR
Patients with active solid organ or hematological malignancies; OR
Patients already receiving therapeutic anticoagulation prior to study recruitment; OR
Patients with thrombosis detected in the insertion site before central catheter insertion; OR
Patients with a central venous catheter already in place prior to ICU admission; OR
Patients admitted to the ICU for post-operative care; OR
Patients admitted to the ICU for trauma care; OR
Patients requiring extra-corporeal life support (ECLS); OR
Patients with poor window or inaccessible for ultrasonographic examination; OR
Pregnancy/post-partum within 6 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients requiring central catheter insertion in the ICU

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Wincy Ng, MRCP	Contact	22553111		wincyngwingsze@gmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital	Recruiting	Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases