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Anticoagulation Post Laparoscopic Splenectomy

NCT00769873 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-06-24

No results posted yet for this study

Summary

Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective studies in the literature have shown the incidence of symptomatic splenic/portal vein thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy. All participants will receive one dose of pre-operative low molecular weight heparin (Lovenox®) subcutaneously, 2 hours prior to surgery. Participants will be randomized pre-operatively to treatment or control group however the treatment allocation will not be revealed until the surgery is complete. Postoperatively, those assigned to the treatment group will receive 40 mg of Lovenox® subcutaneously once a day for 21 days; those in the control group will not. Patients with severe renal impairment will receive an adjusted dose of Lovenox® (30 mg subcutaneous dose daily). All patients will have a baseline abdominal Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have their lipase and liver function tests checked to correlate with the imaging findings.

Conditions

  • Portal Vein Thrombosis
  • Splenic Vein Thrombosis

Interventions

DRUG

Enoxaparin

Lovenox 40mg SC daily (30mg SC daily if creatinine clearance \< 30) for 21 days

Sponsors & Collaborators

  • Edmonton Civic Employees Research Fund

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • University of Alberta

    lead OTHER

Principal Investigators

  • James Shapiro, MD PhD FRCS(Eng) · University of Alberta

  • Haili Wang, MD FRCSC · University of Alberta

  • Daniel Kopac, MD MSc · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • Canada

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769873 on ClinicalTrials.gov