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

Completed

• Conditions: Chemotherapy-induced Thrombocytopenia

• Registration Number: NCT05688306
• Lead Sponsor: Liaoning Tumor Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-02
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2023-01-15
• Last Update Submitted: 2023-01-15
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3494

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the incidence of thrombosis.	1 month after treatment.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xing Xiaojing; 🇨🇳 Shenyang, Liaoning, China