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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

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 - RCT of Combined Enoxaparin/IPC vs. IPC Alone in Postoperative Gynecologic Oncology Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005333
Enrollment
240
Registered
2011-04-01
Start date
2011-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic malignancy

Interventions

Participants allocated to the combined enoxaparin/IPC group will receive intermittent pneumatic compression starting just before the surgery until they receive their first injection of enoxaparin (9:3

Sponsors

The Jikei University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients more than or equal to 40 years old Patients more than or equal to 40 kg Patients receiving a surgery* for gynecologic malignancy Patients whose informed consent is obtained *: Surgery is defined as an abdominal surgery or other surgeries which take more than 45 minutes.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Symptomatic/asymptomatic venous thromboembolism (deep venous thrombosis and pulmonary thromboembolism)

Secondary

MeasureTime frame
Clinically apparent bleeding events developed after 9:30 PM, postoperative day 1 Thrombocytopenia developed after 9:30 PM, postoperative day 1

Countries

Japan

Contacts

Public ContactChie Nagata

The Jikei University School of Medicine Department of Obstetrics and Gynecology

chienagata@jikei.ac.jp03-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026