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

NCT ID: NCT05939960

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal group

GCT time within normal range;Normal coagulation function

CGT test

Intervention Type DIAGNOSTIC_TEST

GCT、PRP-CT、PPP-CT monitor

hypercoagulable group

GCT time reduction; Normal coagulation function,

CGT test

Intervention Type DIAGNOSTIC_TEST

GCT、PRP-CT、PPP-CT monitor

Interventions

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CGT test

GCT、PRP-CT、PPP-CT monitor

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiong Qin

Director of Oncology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhang Jianning, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Locations

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Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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donglai Jin, Doctor

Role: CONTACT

862260363203

Yi Wang, Doctor

Role: CONTACT

862260361044

Facility Contacts

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Qiong Qin, Doctor

Role: primary

862260814993

Other Identifiers

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IRB2023-RTFL-134

Identifier Type: -

Identifier Source: org_study_id

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