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

NCT05688306 | Completed

• 1 other identifier: IL-11xs
• Study Type: observational
• Target: 3,494
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• To assess the incidence of thrombosis.

  1 month after treatment.

Secondary Outcomes (3)

• To evaluate the absolute count of platelets.

  1 month after treatment.

• To evaluate the level D-dimer.

  1 month after treatment.

• To examine the coagulation function index.

  1 month after treatment.

Interventions

Recombinant Human Interleukin-11 for Injection DRUG

received rhIL-11 injection for at least 5 consecutive days

Also known as: rhIL-11

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pathological diagnosis of solid tumors or lymphomas

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead

Study Sites (1)

Xing Xiaojing

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Interventions

Interleukin-11; Injections; oprelvekin

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xiaojing Xing

  Liaoning Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 18, 2023
• Study Start: September 2, 2020
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: January 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)