UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005333 |
|---|---|
| Receipt number | 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 11:19:13 |
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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
| Obstetrics 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
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
chienagata@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006337
