Clareo Health | A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Beijing Suncadia Pharmaceuticals Co., Ltd
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Aged ≥ 18 years old on the day of signing the informed consent form;
2. Diagnosed as stage III-IV or recurrent ovarian cancer;
3. Have surgical indications and no contraindications to surgery, and voluntarily undergo laparotomy or laparoscopic surgery to treat ovarian cancer;
4. Understand the research procedures and methods, voluntarily participate in this trial, and sign the written informed consent form.
You may not be if
1. The primary site of the tumor is not the ovary or there is brain metastasis;
2. A history that may increase the risk of bleeding;
3. A history of VTE in the past or during screening, or a disease that increases thrombosis tendency such as protein C deficiency;
4. Patients with atrial fibrillation requiring anticoagulant treatment or the use of artificial heart valves during screening;
5. Acute coronary syndrome within 3 months;
6. Poorly controlled hypertension before screening, and uncontrolled hypertension within 6 months severe cardiac arrhythmia;
8. Have had a history of adverse reactions or allergies related to rivaroxaban or enoxaparin, such as heparin-induced thrombocytopenia;
9. Have used any drugs prohibited other than investigational drugs within 7 days before screening or plan to use during the study;
10. Those who have participated in any drug intervention clinical trial within 1 month before screening, or those who are within 5 half-lives of the investigational drug at the time of screening, Whichever is longer;
11. Those who are expected to use postoperative neuraxial analgesia;
12. Those who are expected to use plantar vein pumps, intermittent pneumatic compression devices, electronic or mechanical muscle stimulators after surgery;
13. Other circumstances in which the researcher believes that the subject is not suitable to participate in this trial.
