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Trial Title:
Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors
NCT ID:
NCT05939960
Condition:
Neoplasm Metastasis
Blood Coagulation Disorder With Shortened Coagulation Time (Disorder)
Venous Thromboembolism
Conditions: Official terms:
Neoplasm Metastasis
Thromboembolism
Venous Thromboembolism
Hemostatic Disorders
Blood Coagulation Disorders
Thrombophilia
Conditions: Keywords:
Neoplasm Metastasis
Blood Coagulation Disorder
Venous Thromboembolism
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CGT test
Description:
GCT、PRP-CT、PPP-CT monitor
Arm group label:
Normal group
Arm group label:
hypercoagulable group
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.
Criteria for eligibility:
Study pop:
According to the commonly used Caprini Thrombosis Risk Score and Khrona Thrombosis Risk
Score in clinical practice, patients with Caprini score ≥ 5 and Khrona score ≥ 2 have a
VTE incidence rate of 8.8% -14.6%; The expected incidence of VTE in patients with
shortened whole blood GCT time is 30%; Based on sample size calculation, Class I error α=
0.025, Class II error β= 0.05, bilateral test, loss of follow-up rate of 10%, calculated
sample size of 76 cases. It is predicted that patients with shortened GCT time account
for 30% of all tumor patients, and 254 patients need to complete GCT testing. Therefore,
the overall sample size required for this study is 254 cases.
Sampling method:
Probability Sample
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300170
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiong Qin, Doctor
Phone:
862260814993
Email:
qinqiong315@tmu.edu.cn
Start date:
July 1, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Tianjin Medical University General Hospital
Agency class:
Other
Source:
Tianjin Medical University General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05939960
