Safety and efficacy of postoperative enoxaparin treatment in patients undergoing curative hepatobiliary-pancreatic cancer surgery: a prospective, Phase Two, multi-center study

JRCT ID: jRCT1051190020

Registered date:20/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: hepatobiliary-pancreatic cancer
• Date of first enrollment: 28/04/2015
• Target sample size: 260
• Study type: Interventional
• Intervention(s): Enoxaparin treatment for 8 days / Physiotherapy only

Outcome(s)

• Primary Outcome: Rate of venous thromboembolism

Secondary Outcome

Rate of bleeding (major or minor bleeding within 30 days)
Rate of adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1,Hepatobiliary-pancreatic cancer with surgical resection.(excluded foe pancreatoduodenectomy or hepatic resection with biliary reconstruction)
2,Aged 40 over years old.
3,Expected for survival of more than 6 months after surgery.
4,Child-Pugh A
5,Informed Consent

Exclude criteria

1 Symptom of deep venous thrombus.
2 Treatment of estrogen or progesterone within 4 weeks before administration.
3 Chemotherapy or radiotherapy within 2 weeks before administration.
4 Receiving anticoagulant (heparin or warfarin), anti-platelet therapy,
aspirin from 2 days before the operation
5 Severe renal dysfunction (less than 30 mL/min of creatinine clearance)
6 Platelet count < 75000/mm^2,
7 APTT > 50
8 History of thrombocytopenia caused by heparin.
9 History of surgery for eye, spinal or central nerve system within 2 weeks.
10 History of peptic ulcer or bleeding within 3 months
11 History of cerebral hemorrhage within 1 year
12 History of allergy for heparin or biological products.
13 Patients with acute bacterial endocarditis
14 Pregnancy
15 others, in the investigator's judgment

Related Information

• Primary Sponsor: Kobayashi Syogo
• Secondary ID(s): UMIN000019368