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Microcirculation in Patients With Leukemic Hyperleukocytosis

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ClinicalTrials.gov Identifier: NCT03729206
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

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.

Condition or disease Intervention/treatment Phase
Hyperleukocytic Syndrome Diagnostic Test: intravital microscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Visualization of Microcirculation in Patients With Leukemic Hyperleukocytosis
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : August 1, 2021

Arm Intervention/treatment
Experimental: Sublingual microscopy Diagnostic Test: intravital microscopy
intravital microscopy with sidestream dark-field imaging




Primary Outcome Measures :
  1. microvascular flow index (MFI) of sublingual microcirculation [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729206


Contacts
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Contact: Christine Eisfeld, MD +4915122303907 christine.eisfeld@ukmuenster.de

Locations
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Germany
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Christine Eisfeld, MD    +492518347587    christine.eisfeld@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Christoph Schliemann, MD University Hospital Muenster
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT03729206    
Other Study ID Numbers: leuko_MedA2018
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No