To Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Thrombocytopenia Treatment

January 15, 2023 updated by: Liaoning Tumor Hospital & Institute

A Real World Observational Study to Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Platelet-raising Therapy

Chemotherapy-induced thrombocytopenia (CIT) is a common hematological toxicity in patients with solid tumors undergo chemotherapy, which can increase the risk of bleeding, prolong hospital stay, increase medical costs, and even lead to death in severe cases. The incidence and severity of CIT varies among different chemotherapy regimens. Recombinant human interleukin-11 (rhIL-11) and recombinant human thrombopoietin (rhTPO) have been approved for the treatment of chemotherapy-induced thrombocytopenia.

Tumor patients are at high risk for venous thromboembolism (VTE). In the clinical study of rhIL-11, it was found that the administration of rhIL-11 in healthy subjects caused an increase in the plasma concentration of vWF factor in the form of normal mults. The application of rhIL-11 in patients with myeloid leukemia can increase the concentration of α2 globulin, fibrinogen and prothrombin time. However, there have been no large-scale clinical studies at home and abroad to evaluate whether platelet raising therapy will increase the risk of thrombosis in chemotherapy patients with solid tumor. This study is aimed to evaluate the efficacy and safety of platelet upwelling therapy in patients with solid tumors undergoing chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Xing Xiaojing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pathological diagnosis of solid tumors or lymphomas

Description

Inclusion Criteria:

  • Patients with pathological diagnosis of solid tumors or lymphomas.
  • Have received chemotherapy.
  • Diagnosed of CIT.
  • Continuous use of platelet raising drugs for at least 5 days.

Exclusion Criteria:

  • Thrombocytopenia caused other than chemotherapy, including but not limited to: traditional Chinese medicine, congenital platelet disease, etc.
  • The basic value of platelet count is continuously higher than 300×10^9/L.
  • Those without blood routine or coagulation function data.
  • Those who received non-chemotherapy drugs that may cause thrombocytopenia, such as sulfonamides.
  • Pseudothrombocytopenia due to Ethylenediamine tetraacetic acid (EDTA) as an anticoagulant in test samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the incidence of thrombosis.
Time Frame: 1 month after treatment.
1 month after treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the absolute count of platelets.
Time Frame: 1 month after treatment.
1 month after treatment.
To evaluate the level D-dimer.
Time Frame: 1 month after treatment.
1 month after treatment.
To examine the coagulation function index.
Time Frame: 1 month after treatment.
1 month after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaoning Tumor Hospital & Institute

Investigators

  • Principal Investigator: Xiaojing Xing, Liaoning Tumor Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

January 15, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL-11xs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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