UMIN-CTR Clinical Trial

Public title

Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.

Acronym

Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.

Scientific Title

Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.

Scientific Title:Acronym

Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Investigate the preventive effect of
VTE and safety of Fondaparinux which is administered 1.5mg/day or 2.5mg/day for 4-8 days (or till discharge from the hospital) after abdominal surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Major bleeding event rate

Key secondary outcomes

Frequency of symptomatic PTE or symptomatic DVT

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Start injection of Fondaparinux from 24 +/- 2 hours after surgery and continue administration for 4-8 days.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients who had Colon cancer surgery and have additional risk factor in Japanese Guideline for Prevention of Venous Thromboembolism
2. Patients who can give informed consent

Key exclusion criteria

Criteria related to contraindication and warnings and precautions of anticoagulant (Fondaparinux, Heparin, LMWH, danapanoid)
1. Patients with Bleeding
2. Patients with thrombocytopenia (platelet count less than 100,000 /uL)
3. Patients with complications which may cause bleeding (exclude the target disease of surgery) such as gastrointestinal ulceration, gastrointestinal diverticulitis, colitis, acute bacterial endocarditis, uncontrolled severe hypertension, uncontrolled diabetes, DIC.
4. Patients with severe Hepatic impairment (Child-pugh Category C )
5. Patients with a history of hypersensitivity to heparine, LMWH, danaparoid.
6. Patients with a history of intracerebral hemorrhage.
7. Patients who received brain, spine and eye surgery within 3 months before registration.
8. Patients with severer bleeding than ordinal perioperative bleeding or with difficulty to hemostasis.
9. Severe renal impairment (CCr: less than 20ml / min)

-Other exclude criteria
1. Patients who received major orthopedic surgery (lower limbs), abdominal surgery and cardiovascular surgery within 3 months before the study registration.
2. Patients who received prohibited concomitant drug as follows; Heparin, LMWH, danaparoid, antithrombotic drug, oral anticoagulant (warfalin) , thrombolytic drug, dextran, anti platelet drug (aspirin, clopidogrel, ticlopidine)
3. Patients who diagnosed as VTE at preoperative test
4. Patients whose preoperative D-dimer values are more than 1ug/ml, or 2 times of standard value in the hospital
5. Patients with a history of arterial thromboembolism.
6. Patients with drug addiction or alcoholism
7. Patients who are scheduled other surgery in the study period
8. pregnancy or possibility of pregnant
9. Patients who were tried insertion more than 2 times when catheterization
Patients who are regarded ineligible by doctors with any other reasons

Target sample size

600

Name of lead principal investigator

1st name
Middle name
Last name	Mitsugu Sekimoto

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Surgery, Gastroenterological Surgery

Zip code

Address

E2-2-2, Yamadaoka, Suita, Osaka

TEL

06-6879-3251

Email

msekimoto@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Masataka Ikeda

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Surgery, Gastroenterological Surgery

Zip code

Address

E2-2-2, Yamadaoka, Suita, Osaka

TEL

06-6879-3251

Homepage URL

Email

mikeda@gesurg.med.osaka-u.ac.jp

Institute

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Institute

Department

Personal name

Organization

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学大学院　医学系研究科 消化器外科学（大阪府）
愛染橋病院（大阪府）
市立芦屋病院（兵庫県）
市立池田病院（大阪府）
市立泉佐野病院（大阪府）
医誠会病院（大阪府）
市立伊丹病院（兵庫県）
町立内海病院（香川県）
NTT西日本大阪病院（大阪府）
国立病院機構　大阪医療センター（大阪府）
大阪警察病院（大阪府）
大阪厚生年金病院（大阪府）
大阪船員保険病院（大阪府）
大阪中央病院（大阪府）
大阪府立急性期・総合医療センター（大阪府）
大阪府立成人病センター（大阪府）
大阪労災病院（大阪府）
大手前病院（大阪府）
市立貝塚病院（大阪府）
加納総合病院（大阪府）
ガラシア病院（大阪府）
川崎病院（兵庫県）
河内総合病院（大阪府）
市立川西病院（兵庫県）
関西労災病院（兵庫県）
社会保険紀南病院（和歌山県）
医誠会病院（大阪府）
近畿大学医学部奈良病院（奈良県）
近畿中央病院（兵庫県）
国立病院機構呉医療センター（広島県）
神戸掖済会病院（兵庫県）
大阪府済生会千里病院（大阪府）
市立堺病院（大阪府）
桜橋渡辺病院（大阪府）
四天王寺病院（大阪府）
市立吹田市民病院（大阪府）
清恵会病院（大阪府）
田仲北野田病院（大阪府）
多根総合病院（大阪府）
市立豊中病院（大阪府）
富田林病院（大阪府）
那智勝浦町立温泉病院（和歌山県）
兵庫県立西宮病院（兵庫県）
西宮市立中央病院（兵庫県）
日生病院（大阪府）
阪和第一泉北病院（大阪府）
阪南中央病院（大阪府）
東大阪市立総合病院（大阪府）
東宝塚さとう病院（兵庫県）
藤本病院（大阪府）
ベルランド総合病院（大阪府）
緑ヶ丘病院（大阪府）
箕面市立病院（大阪府）
守口敬任会病院（大阪府）
八尾市立病院（大阪府）

Date of disclosure of the study information

2012

Year

01

Month

16

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4194009/

Number of participants that the trial has enrolled

Results

Fondaprinux was safe and effective in patients with colorectal cancer resection for the prevention of VTE.

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

Recruitment status

Completed

Date of protocol fixation

2009

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

2010

Year

12

Month

31

Day

Date of closure to data entry

2011

Year

12

Month

31

Day

Date trial data considered complete

2011

Year

12

Month

31

Day

Date analysis concluded

2012

Year

12

Month

31

Day

Other related information

Registered date

2012

Year

01

Month

16

Day

Last modified on

2015

Year

07

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003708