Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors

Study Overview
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Brief Summary
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Malignant tumors are closely related to deep vein thrombosis, Pulmonary embolism and other diseases. Tumor patients usually have a hypercoagulable state (HCS) in their blood, and the proportion of thrombosis caused by HCS is more than 10 times that of non tumor patients. Conventional clinical testing methods such as coagulation function, blood routine, and thromboelastography are difficult to directly evaluate the hypercoagulable state of tumor patients. In addition, the widely used Khorana score and Caprini score systems in clinical practice need to be improved in accurately reflecting the hypercoagulable state of tumor patients. Our team has established a complete new coagulation time measurement system, including general clotting time (GCT), platelet rich plasma clotting time (PRP-CT), and platelet poor plasma clotting time (PPP-CT), which may be a new and accurate method for evaluating tumor hypercoagulability. The GCT study aims to evaluate: 1. The time of GCT, PRP-CT, and PPP-CT for malignant tumors is shorter than that of normal individuals, and some patients are in a hypercoagulable state; 2. The shortened time of GCT, PRP-CT, and PPP-CT may be associated with future thrombosis; 3. Evaluating the relationship between shortened GCT system time and overall tumor survival Therefore, the GCT system evaluation may identify patients who are truly in a hypercoagulable state, providing monitoring indicators for subsequent anticoagulation; It can also be evaluated whether GCT time can reflect the prognosis of tumor patients.

Official Title
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Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors

Conditions
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Neoplasm Metastasis, Blood Coagulation Disorder With Shortened Coagulation Time (Disorder), Venous Thromboembolism

Intervention / Treatment
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* Diagnostic Test: CGT test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily participate and sign an informed consent form; Age ≥ 18 years old Expected survival time>6 months; Patients diagnosed with malignant tumors for the first time or progressing during treatment; Solid malignant tumors with clear pathological diagnosis; ECOG physical fitness score ≤ 2 points Exclusion Criteria: Patients with known venous thrombosis (including upper and lower limb venous thrombosis, Pulmonary embolism, visceral venous thrombosis, etc.); Patients who have received long-term treatment with Warfarin, Rivaroxaban, and low-molecular-weight heparin (except aspirin, hydrogen Clopidogrel, etc.); Patients with active infections and sepsis; Hematology tumor (except lymphoma); Patients who undergo any major surgical treatment within 28 days prior to enrollment;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal group<br>GCT time within normal range；Normal coagulation function | Diagnostic Test: CGT test<br>* GCT、PRP-CT、PPP-CT monitor<br>|
| hypercoagulable group<br>GCT time reduction； Normal coagulation function, | Diagnostic Test: CGT test<br>* GCT、PRP-CT、PPP-CT monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames | Compared with non tumor patients, the GCT time of tumor patients is significantly shortened | July 1,2023 to September 30,2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| theincreased incidence of VTE | In patients with shortened GCT, the incidence of VTE increases. | July 1,2023 to September 30,2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm Metastasis, Blood Coagulation Disorder, Venous Thromboembolism