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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05688306

Enrollment

3494

Registered

2023-01-18

Start date

2020-09-02

Completion date

2022-05-16

Last updated

2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Thrombocytopenia

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.

Interventions

DRUGRecombinant Human Interleukin-11 for Injection

received rhIL-11 injection for at least 5 consecutive days

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To assess the incidence of thrombosis.	1 month after treatment.

Secondary

Measure	Time frame
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026