VENUS study

JRCT ID: jRCTs051240203

Registered date:02/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pulmonary thromboembolism
• Date of first enrollment: 02/12/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Enoxaparin sodium administration in the early postoperative period

Outcome(s)

• Primary Outcome: Incidence of Major Bleeding

Secondary Outcome

1) Incidence of Minor Bleeding
2) Incidence of HIT
3) Incidence of postoperative symptomatic PTE
4) Incidence of postoperative DVT

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

[Primary enrollment]
1)Patients scheduled to undergo surgical treatment for gynecological tumors (including benign and malignant tumors) at Nara Medical University Hospital
2) Patients with any of the following risk factors for PTE
<Risk factors for PTE>
(1) Risk of the case
Malignant disease or suspected malignant disease
Large ovarian mass or myoma occupying the pelvic cavity.
(2) Risks associated with the disease or surgery
Neoadjuvant chemotherapy prior to surgery.
Severe infectious diseases
Bed rest for more than 48 hours before surgery.
Bed rest for more than 48 hours after surgery.
Central venous catheter
(3) Risks associated with the background of each patient
Age >= 60 years old
BMI >= 25
Previous history of venous thrombosis
Thrombophilia or family history of venous thrombosis
Hormone therapy
Severe varicose veins of the lower extremities
Congestive heart failure or respiratory failure
Paralysis of the lower limbs
3) Patients aged 18 years and over
4) Patients with written consent
[Secondary enrollment]
1) Patients who were enrolled in the primary registry
2) Patients who have undergone surgery

Exclude criteria

[At the time of primary enrollment]
1) Bleeding from causes other than the primary disease
2) Thrombocytopenia (platelet count < 100,000/microL)
3) The following hemorrhagic complications; gastrointestinal ulcer, gastrointestinal diverticulitis, colitis, acute bacterial endocarditis, poorly controlled severe hypertension (systolic >=180 mmHg or diastolic >=120 mmHg), poorly controlled severe diabetes (HbA1c >=10%), disseminated intravascular coagulation (DIC), and others.
4) Severe hepatic dysfunction (e.g., ALT more than 3 times the institutional reference value)
5) Hypersensitivity to heparin, low molecular weight heparin, or danaparoid
6) History of cerebral hemorrhage
7) Central nervous system surgery or ophthalmic surgery within 3 months
8) Creatinine clearance < 40 ml/min
9) History or suspected history of heparin-induced thrombocytopenia (HIT)
10) Preoperative pulmonary thromboembolism or deep vein thrombosis
11) Taking anticoagulants or antiplatelet agents
12) Extreme emaciation
13) Patients deemed by the physician to be inappropriate for registration.
[At the time of Secondary enrollment]
1) Patients who are considered to be unable to undergo protocol treatment due to intraoperative or postoperative bleeding

Related Information

• Primary Sponsor: Kawaguchi Ryuji
• Source(s) of Monetary Support: JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE