Microcirculation in Patients With Leukemic Hyperleukocytosis

November 4, 2022 updated by: University Hospital Muenster

Visualization of Microcirculation in Patients With Leukemic Hyperleukocytosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, 48149
        • Universitätsklinikum Münster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sublingual microscopy
Diagnostic test: intravital microscopy
intravital microscopy with sidestream dark-field imaging

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Christoph Schliemann, MD, University hospital Muenster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • leuko_MedA2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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