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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05939960
Acronym
GCTHCM
Enrollment
354
Registered
2023-07-11
Start date
2023-07-01
Completion date
2024-09-30
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Neoplasm Metastasis, Blood Coagulation Disorder, Venous Thromboembolism

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.

Interventions

DIAGNOSTIC_TESTCGT test

GCT、PRP-CT、PPP-CT monitor

Sponsors

Tianjin Medical University General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplamesJuly 1,2023 to September 30,2024Compared with non tumor patients, the GCT time of tumor patients is significantly shortened

Secondary

MeasureTime frameDescription
theincreased incidence of VTEJuly 1,2023 to September 30,2024In patients with shortened GCT, the incidence of VTE increases.

Countries

China

Contacts

Primary Contactdonglai Jin, Doctor
zyyjgb_ll@163.com862260363203
Backup ContactYi Wang, Doctor
zyyjgb_ms@163.com862260361044

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026