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Post-thrombotic Syndrome After Deep Venous Thrombosis (DVT) in Patients Treated According to the NOPHO ALL2008 Protocol

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ClinicalTrials.gov Identifier: NCT04825548
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Birgitte Klug Albertsen, Aarhus University Hospital

Study Description
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Brief Summary:

Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Today more than 90% of children and 75% of adults (18-45 years) survive ALL. The enzyme Asparaginase (Asp) is an indispensable part of the multiagent treatment of ALL.

Treatment related severe acute toxicities are common. Especially in teenagers and adults, thromboembolism is one of the most common acute toxicities and may result in post thrombotic syndrome (PTS) or pulmonary hypertension. The knowledge about these late effects is limited, including for ALL patients.


Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Post Thrombotic Syndrome Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Post-thrombotic Syndrome After Deep Venous Thrombosis (DVT) in Patients Treated According to the NOPHO ALL2008 Protocol
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    Examination of patients with previous DVT

Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with post thrombotic syndrome [ Time Frame: 01112020-01022023 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients between 1.0-45 years of age and diagnosed with DVT and PE during treatment on the NOPHO ALL2008 protocol. In this period, 115 patients were diagnosed with DVT
Criteria

Inclusion Criteria:

  • Treated on the ALL2008 protocol for ALL. Had a DVT on treatment.

Exclusion Criteria:

  • Death
Contacts and Locations
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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): NCT04825548


Contacts
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Contact: Birgitte K Albertsen, MD 20224643 biralber@rm.dk
Contact: Merete E Dam, MD 27268201 meretdam@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus N, Vælg En Region, Stat Eller Provins., Denmark, 8200
Contact: Merete Dam. MD. Phd student Aarhus University H Denmark    27268201    meretdam@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital
More Information
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Responsible Party: Birgitte Klug Albertsen, M.D., PhD, Associate Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04825548    
Other Study ID Numbers: PTS-NOPHOALL2008
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Syndrome
Disease
Pathologic Processes
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases