Influence of Vasopressors on Anti-Xa Activity in Critical... | NCT06055907

Studies
Influence of Vasopressors on Anti-Xa Activity in Critically Ill Patients

NCT06055907

Sponsor

Medical University of Gdansk

Status

Unknown status

Last Update Posted

Sep 28, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Critical Illness
Thrombosis

Interventions

Serum anti-Xa activity

Countries

Poland

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

Sep 2023

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

May 15, 2023Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Sep 20, 2023

First Submission Date that Met QC Criteria

Sep 20, 2023

First Posted Date

Sep 28, 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

Sep 20, 2023

Last Update Posted Date

Sep 28, 2023Actual

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

Description Module

Brief Summary

Critically ill patients require antithrombotic prophylaxis. At the same time, majority of them is receiving various vasopressors. The aim of the study is to determine whether there is a difference in anti-Xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients receiving norepinephrine with argipressin, compared to those receiving norepinephrine alone.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NOR+ARG		Critically ill patients receiving norepinephrine and argipressin, with antithrombotic prophylaxis with 5000 IU of dalteparin.	Diagnostic Test: Serum anti-Xa activity
NOR		Critically ill patients receiving norepinephrine alone, with antithrombotic prophylaxis with 5000 IU of dalteparin.	Diagnostic Test: Serum anti-Xa activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum anti-Xa activity	Diagnostic Test	4 hours after third dose of dalteparin, serum anti-Xa activity is measured	NOR NOR+ARG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-Xa activity	IU anty-Xa/ml	4 hours after third dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Circulatory failure
Supported by continuous infusion of noradrenaline or noradrenaline and argipressin
Receiving subcutaneous dalteparin for the prevention of venous thromboembolism.

Exclusion Criteria:

Contraindications for dalteparin
Severe coagulopathy
Acute or subacute bacterial endocarditis
Pregnant women
BMI (body mass index) > 30kg/m2
Chronic kidney disease with eGFR (estimated glomerular filtration rate) < 30 ml/min/1.73 m2
Renal replacement therapy
The patient died within 52 hours of starting VTE (venous thromboembolism) prophylaxis with dalteparin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

The cohort study will be conducted on a population of 50 adult patients of both sexes treated in the Intensive Care Unit at the University Clinical Center in Gdansk, Poland.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Stefaniak, MD.	Contact	505694054	0048	jan.stefaniak@gumed.edu.pl

Overall Officials

Name	Affiliation	Role
Radosław Owczuk, MD., PhD., Prof.	Medical University of Gdansk	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care	Recruiting	Gdansk		80-214	Poland

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D013927	Thrombosis

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D016769	Embolism and Thrombosis

Browse Leaves

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Browse Branches

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