Clinical trial NCT05688306: To Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Thrombocytopenia Treatment
Official title: A Real World Observational Study to Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Platelet-raising Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Thrombocytopenia
Lead sponsor: Liaoning Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 3494
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathological diagnosis of solid tumors or lymphomas

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the incidence of thrombosis.
timeFrame: 1 month after treatment.
Secondary outcomes:
measure: To evaluate the absolute count of platelets.
timeFrame: 1 month after treatment.
measure: To evaluate the level D-dimer.
timeFrame: 1 month after treatment.
measure: To examine the coagulation function index.
timeFrame: 1 month after treatment.
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Xing Xiaojing
state: Liaoning
Study officials:
affiliation: Liaoning Cancer Hospital & Institute
name: Xiaojing Xing
role: PRINCIPAL_INVESTIGATOR
References: