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

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.

Study Overview

• Status: Completed
• Conditions: Acute Lymphoblastic Leukemia; Post Thrombotic Syndrome
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Denmark
  • Vælg En Region, Stat Eller Provins.
    • Aarhus N, Vælg En Region, Stat Eller Provins., Denmark, 8200
      • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Death

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with post thrombotic syndrome	01112020-01022023

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease; Embolism and Thrombosis; Leukemia, Lymphoid; Leukemia; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: PTS-NOPHOALL2008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No