A Randomized Controlled Trial of Enoxaparin Combined with Intermittent Pneumatic Compression versus Intermittent Pneumatic Compression Alone as Prophylaxis against Thromboembolism in Postoperative Gynecologic Oncology Patients

Phase 3

• Conditions: Gynecologic malignancy

• Registration Number: JPRN-UMIN000005333
• Lead Sponsor: The Jikei University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-01
• Study Completion: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with venous thromboembolism Patients allergic to enoxaparin and/or heparin/heparin derivatives Patients with active bleeding (intracranial hemorrhage, retroperitoneal hemorrhage, and/or hemorrhage from other major organs) or at higher risk of bleeding (hemostatic disorder, gastric ulcer, recent ischemic stroke, uncontrollable hypertension, diabetic retinopathy, and/or recent brain or eye surgery) Patients with acute bacterial endocarditis Patients with severe renal dysfunction (CCr < 50ml/min = eGFR < 40ml/min/1.73m2) Patients with severe liver dysfunction Patients with history of heparin induced thrombocytopenia (HIT) Patients with history of venous thromboembolism and/or thrombotic tendency Patients taking anticoagulants, platelet aggregation inhibitors, salicylic acid derivatives, and/or thrombolytic drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic/asymptomatic venous thromboembolism (deep venous thrombosis and pulmonary thromboembolism)

Secondary Outcome Measures

Name	Time	Method
Clinically apparent bleeding events developed after 9:30 PM, postoperative day 1 Thrombocytopenia developed after 9:30 PM, postoperative day 1