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

Chemotherapy-induced Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688306
• Other study ID #: IL-11xs
• Status: Completed
• Start date: September 2, 2020
• Est. completion date: May 16, 2022

Study information

• Verified date: December 2022
• Source: Liaoning Tumor Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3494
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Thrombocytopenia
• Thrombocytopenia
• Thrombosis

Intervention

Drug:
• Recombinant Human Interleukin-11 for Injection
received rhIL-11 injection for at least 5 consecutive days

Locations

Country	Name	City	State
China	Xing Xiaojing	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Liaoning Tumor Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the incidence of thrombosis.		1 month after treatment.
Secondary	To evaluate the absolute count of platelets.		1 month after treatment.
Secondary	To evaluate the level D-dimer.		1 month after treatment.
Secondary	To examine the coagulation function index.		1 month after treatment.