pulmonary thromboembolism
Conditions
Interventions
Enoxaparin sodium administration in the early postoperative period
Sponsors
Kawaguchi Ryuji
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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 (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
Exclusion criteria
Exclusion criteria: [At the time of primary enrollment] 1) Bleeding from causes other than the primary disease 2) Thrombocytopenia (platelet count =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Major Bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of Minor Bleeding 2) Incidence of HIT 3) Incidence of postoperative symptomatic PTE 4) Incidence of postoperative DVT | — |
Contacts
Public ContactKeita Waki
Nara Medical University Hospital
Outcome results
None listed