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

Recruiting

• Conditions: Blood Coagulation Disorder With Shortened Coagulation Time (Disorder); Neoplasm Metastasis; Venous Thromboembolism
• Interventions: Diagnostic Test: CGT test

• Registration Number: NCT05939960
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-07-01
• Study First Submitted QC: 2023-07-01
• Last Update Submitted: 2023-07-01
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-02-28
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

1. Voluntarily participate and sign an informed consent form;
2. Age ≥ 18 years old
3. Expected survival time>6 months;
4. Patients diagnosed with malignant tumors for the first time or progressing during treatment;
5. Solid malignant tumors with clear pathological diagnosis;
6. ECOG physical fitness score ≤ 2 points

Exclusion Criteria

1. Patients with known venous thrombosis (including upper and lower limb venous thrombosis, Pulmonary embolism, visceral venous thrombosis, etc.);
2. Patients who have received long-term treatment with Warfarin, Rivaroxaban, and low-molecular-weight heparin (except aspirin, hydrogen Clopidogrel, etc.);
3. Patients with active infections and sepsis;
4. Hematology tumor (except lymphoma);
5. Patients who undergo any major surgical treatment within 28 days prior to enrollment;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hypercoagulable group	CGT test	GCT time reduction； Normal coagulation function,
Normal group	CGT test	GCT time within normal range；Normal coagulation function

Primary Outcome Measures

Name	Time	Method
Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames	July 1,2023 to September 30,2024	Compared with non tumor patients, the GCT time of tumor patients is significantly shortened

Secondary Outcome Measures

Name	Time	Method
theincreased incidence of VTE	July 1,2023 to September 30,2024	In patients with shortened GCT, the incidence of VTE increases.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China