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A randomized controlled trial for assessing the effectiveness and safety of patients with abdominal or pelvic tumors receiving prolonged postoperative thromboprophylaxis

A multi-center randomized controlled trial for assessing the effectiveness and safety of patients with abdominal or pelvic tumors receiving prolonged postoperative thromboprophylaxis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016229
Enrollment
Unknown
Registered
2018-05-21
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

venous thromboembolism

Interventions

test group:standard prolonged thromboprophylaxis with low molecular weight heparin till 4 weeks after operation
control group:routine non-standard postoperative thromboprophylaxis

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients are clearly pathologically diagnosed abdominal or pelvic malignant tumors (from general surgery department, gynecology department, urology department, etc.; including laparoscopic and open surgery); 2. Caprini score = 8 points; 3. Expecting life span = 6 months; 4. Patients need to receive routine VTE prophylaxis during hospitalization after operation (physical prevention and pharmaceutical prevention); 5. Tumor stage = 2.

Exclusion criteria

Exclusion criteria: 1. Catheter-related DVT; 2. Past history of VTE or vascular diseases, such as varicose veins and phlebitis; 3. Having received other surgical treatment in 6 months; 4. Clinical manifestations of complicating DVT/PE, but not comfirmed by imaging examination; 5. Past history of blood disorders or severe coagulation dysfunction; 6. Severe liver and renal dysfunction; 7. Long-term use of antithrombotic drugs before surgery; 8. Incomplete clinical data (diagnosis is not clear, medical history is incomplete, medication records are incomplete, etc.); 9. Presence of contraindications to heparin/anticoagulation, heparin allergy/HIT; 10. With heart failure, respiratory failure, refractory hypertension; 11. Pregnancy/lactation.

Design outcomes

Primary

MeasureTime frame
VTE occurrence in the 4th week after operation;VTE occurrence in the 8th week after operation;

Secondary

MeasureTime frame
all-cause mortality in the 4th week after operation;all-cause mortality in the 8th week after operation;duration from operation to VTE occurrence;

Countries

China

Contacts

Public ContactErzhen Chen

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

chenerzhen@hotmail.com+86 021-64372344

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026