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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005333
Receipt No. R000006337
Scientific Title 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
Date of disclosure of the study information 2011/04/01
Last modified on 2016/07/14

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Basic information
Public title 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
Acronym RCT of Combined Enoxaparin/IPC vs. IPC Alone in Postoperative Gynecologic Oncology Patients
Scientific Title 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
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Tadao Tanaka
Organization The Jikei University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-25-8 Nishi-Shimbashi Minato-ku Tokyo-to
TEL 03-3433-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chie Nagata
Organization The Jikei University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 02 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000006337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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