Microcirculation in Patients With Leukemic Hyperleukocytosis | NCT03729206

Studies
Microcirculation in Patients With Leukemic Hyperleukocytosis

NCT03729206

Sponsor

University Hospital Muenster

Status

Completed

Last Update Posted

Nov 7, 2022Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Hyperleukocytic Syndrome

Interventions

intravital microscopy

Countries

Germany

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

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Aug 1, 2021Actual

First Submitted Date

Oct 31, 2018

First Submission Date that Met QC Criteria

Nov 1, 2018

First Posted Date

Nov 2, 2018Actual

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

Nov 4, 2022

Last Update Posted Date

Nov 7, 2022Actual

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

Hyperleukocytosis in patients with acute leukemia impacts rheology and microvascularization, leading to severe symptoms or even death. The investigators investigated whether blood stream alterations induced by hyperleukocytosis can be detected by sidestream dark-field imaging and whether they correlate with the grade of symptoms.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sublingual microscopy	Experimental		Diagnostic Test: intravital microscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravital microscopy	Diagnostic Test	intravital microscopy with sidestream dark-field imaging	Sublingual microscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microvascular flow index (MFI) of sublingual microcirculation		24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute leukemia
de-novo or relapsed stage
able to give consent

Exclusion Criteria:

severe oral mucositis
unable to give consent
pregnant women
patients hospitalized for psychiatric disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph Schliemann, MD	University Hospital Muenster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Münster		Münster		48149	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069416	Intravital Microscopy

Ancestor Terms

ID	Term
D008853	Microscopy
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided