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Clinical Trials/NCT05939960
NCT05939960
Recruiting
Not Applicable

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

Tianjin Medical University General Hospital1 site in 1 country354 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasm Metastasis
Sponsor
Tianjin Medical University General Hospital
Enrollment
354
Locations
1
Primary Endpoint
Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qiong Qin

Director of Oncology Department

Tianjin Medical University General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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;

Outcomes

Primary Outcomes

Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames

Time Frame: July 1,2023 to September 30,2024

Compared with non tumor patients, the GCT time of tumor patients is significantly shortened

Secondary Outcomes

  • theincreased incidence of VTE(July 1,2023 to September 30,2024)

Study Sites (1)

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