Microcirculation in Patients With Leukemic Hyperleukocytosis
Sponsor
University Hospital Muenster (Other)
Overall Status
Unknown status
CT.gov ID
NCT03729206
Collaborator
(none)
40
1
1
36
1.1
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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
:
Aug 1, 2018
Anticipated Primary Completion Date
:
Dec 1, 2020
Anticipated Study Completion Date
:
Aug 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sublingual microscopy
|
Diagnostic Test: intravital microscopy
intravital microscopy with sidestream dark-field imaging
|
Outcome Measures
Primary Outcome Measures
- microvascular flow index (MFI) of sublingual microcirculation [24 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Münster | Münster | Germany | 48149 |
Sponsors and Collaborators
- University Hospital Muenster
Investigators
- Principal Investigator: Christoph Schliemann, MD, University Hospital Muenster
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT03729206
Other Study ID Numbers:
- leuko_MedA2018
First Posted:
Nov 2, 2018
Last Update Posted:
Apr 3, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No