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

Venous Thromboembolism Clinical Trial

— GCTHCM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939960
• Other study ID #: IRB2023-RTFL-134
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: Tianjin Medical University General Hospital
• Contact: donglai Jin, Doctor
• Phone: 862260363203
• Email: zyyjgb_ll[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: September 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Neoplasm Metastasis
• Neoplasms
• Thromboembolism
• Thrombophilia
• Venous Thromboembolism

Intervention

Diagnostic Test:
• CGT test
GCT?PRP-CT?PPP-CT monitor

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	theincreased incidence of VTE	In patients with shortened GCT, the incidence of VTE increases.	July 1,2023 to September 30,2024