UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	RCT of Combined Enoxaparin/IPC vs. IPC Alone in Postoperative Gynecologic Oncology Patients
Region	Japan

Condition
Condition	Gynecologic malignancy
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate and compare the efficacy of enoxaparin combined with intermittent pneumatic compression and intermittent pneumatic compression alone as prophylaxis against venous thromboembolism after gynecologic oncology surgery To evaluate and compare the safety of enoxaparin combined with intermittent pneumatic compression and intermittent pneumatic compression alone
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Symptomatic/asymptomatic venous thromboembolism (deep venous thrombosis and pulmonary thromboembolism)
Key secondary outcomes	Clinically apparent bleeding events developed after 9:30 PM, postoperative day 1 Thrombocytopenia developed after 9:30 PM, postoperative day 1

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment
Interventions/Control_1	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 (9:30 PM, postoperative day 1). They will also receive a subcutaneous injection of enoxaparin (20mg, twice a day) starting 9:30 PM, postoperative day 1 for 7 days.
Interventions/Control_2	Participants allocated to the IPC alone group will receive intermittent pneumatic compression starting just before the surgery for 3-4 days until they become fully ambulant.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key 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.
Key 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
Target sample size	240

Research contact person
Name of lead principal investigator	Tadao Tanaka
Organization	The Jikei University School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	3-25-8 Nishi-Shimbashi Minato-ku Tokyo-to
TEL	03-3433-1111
Email

Public contact
Name of contact person	Chie Nagata
Organization	The Jikei University School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	3-25-8 Nishi-Shimbashi Minato-ku Tokyo-to
TEL	03-3433-1111
Homepage URL
Email	chienagata@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京慈恵会医科大学附属病院(東京都)/The Jikei University Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 02 Month 28 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 03 Month 28 Day
Last modified on	2016 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006337