Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
结局指标
主要结局
Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames
时间窗: July 1,2023 to September 30,2024
Compared with non tumor patients, the GCT time of tumor patients is significantly shortened
次要结局
- theincreased incidence of VTE(July 1,2023 to September 30,2024)
研究者
Qiong Qin
Director of Oncology Department
Tianjin Medical University General Hospital