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Completed

NCT Number: NCT05688306

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Xing Xiaojing

Shenyang, Liaoning, 110000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant Human Interleukin-11 for Injection

Drug

received rhIL-11 injection for at least 5 consecutive days

Other names: rhIL-11

Primary outcomes

  1. To assess the incidence of thrombosis.

    Time frame: 1 month after treatment.

Secondary outcomes

  1. To evaluate the absolute count of platelets.

    Time frame: 1 month after treatment.

  2. To evaluate the level D-dimer.

    Time frame: 1 month after treatment.

  3. To examine the coagulation function index.

    Time frame: 1 month after treatment.

Sponsors and collaborators

Lead sponsor

Liaoning Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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