Clinical study of Zhishen Yuanhu anticoagulant formula in prevention of venous thromboembolism in malignant tumor: a multicenter prospective randomized controlled clinical trial

Phase 1

Recruiting

• Conditions: venous thromboembolism in malignant tumor

• Registration Number: ITMCTR2000004029
• Lead Sponsor: uzhou People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

(1) Aged > 18 years;
(2) There is no contraindication to anticoagulation therapy, and the expected survival is greater than 6 months.
(3) Malignant tumors that occur in the pancreas, ovary, brain, stomach, gynecology, colon, lung, and hematology, and patients who have undergone surgery, radiotherapy and chemotherapy, or whose tumors are in advanced, advanced, and cachexia;
(4) Normal coagulation function: PT 1216s, INR 0.81.5, APTT2436s, FIB24g/L;
(5) Creatinine clearance rate> 20 ml/min;
(6) Khorana scores are middle-high risk patients; (see appendix for Khorana scoring criteria);
(7) Doppler ultrasonography before operation has no DVT;
(8) The patient expressed informed consent and signed an informed consent form;
(9) The test group ( Zhishen Yuanhu anticoagulant formula group) additional inclusion criteria: spleen and kidney yang deficiency, blood stasis type.

Exclusion Criteria

(1) Known allergy to low molecular weight heparin sodium, leech, Yuanhu or Codonopsis;
(2) Those with severe vascular sclerosis;
(3) Those suffering from phlebitis of the lower extremities;
(4) Patients with lower limb edema or pulmonary edema caused by congestive heart failure;
(5) People with recent coagulation dysfunction or active bleeding from important organs;
(6) Those with open wounds or skin infections on the skin of the lower limbs;
(7) The test group (Zhishen Yuanhu anticoagulant formula group) additional exclusion criteria: damp-heat type (corresponding to thrombosis, acute phase), heterologous protein allergy, yellow and thick tongue coating.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Hcy and P-selection;Coagulation index;Hemorheology Index;Deep venous thrombosis;

Secondary Outcome Measures

Name	Time	Method
ower limb circumference;Tongue coating;