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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04825548
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Information provided by (Responsible Party):
Birgitte Klug Albertsen, Aarhus University Hospital

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

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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

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

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

Information from the National Library of Medicine

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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

Inclusion Criteria:

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

Exclusion Criteria:

  • Death

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 identifier (NCT number): NCT04825548

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Contact: Birgitte K Albertsen, MD 20224643
Contact: Merete E Dam, MD 27268201

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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   
Sponsors and Collaborators
Aarhus University Hospital
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Responsible Party: Birgitte Klug Albertsen, M.D., PhD, Associate Professor, Aarhus University Hospital 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
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Pathologic Processes
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Peripheral Vascular Diseases