Official Title: "Effect of Anticoagulation in Reducing the Incidence of Splenic/Portal Vein Thrombosis Post-Laparoscopic Splenectomy Protocol Number: 5698"
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
- Study Primary Completion Date: April 2009
Interventions Used in this Clinical Trial
- Drug: Enoxaparin
- Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Lovenox
- Patients receive Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days after laparoscopic splenectomy
- No Intervention: No Lovenox
- Patients do NOT receive Lovenox post laparoscopic splenectomy
Outcome Measures for this Clinical Trial
- The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy
- Time Frame: three years
Safety Issue?: Yes
- Time Frame: three years
Criteria for Participation in this Clinical Trial
- Scheduled to undergo laparoscopic splenectomy at The University of Alberta or Grey Nun's Community Hospitals
- Capable of understanding the purpose and risks of the study and willing/able to sign a statement of informed consent
- Willing to undergo daily subcutaneous injections of Lovenox®
- Pregnant or nursing
- Unable or unwilling to provide informed consent
- Bleeding diathesis or currently on anticoagulation therapy (i.e. coumadin, heparin, LMWH)
- Hemorrhagic cerebral vascular accident
- Severe uncontrolled hypertension
- Diabetic or hemorrhagic retinopathy
- Contradictions to anticoagulation (i.e. active GI bleed, gastric or duodenal ulcer, sustained platelet count < 50 x103/uL, splenectomy due to trauma or history of heparin induced thrombocytopenia)
- Conversion to open splenectomy
- Allergy to Lovenox®, heparin, or other low molecular weight heparins
- Bacterial endocarditis
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- University of Alberta
- Edmonton Civic Employees Research Fund
- Provider of Information About this Clinical Study
- Dr. James Shapiro, University of Alberta
- Overall Official(s)
- James Shapiro, MD PhD FRCS(Eng), Principal Investigator, University of Alberta
- Haili Wang, MD FRCSC, Study Director, University of Alberta
- Daniel Kopac, MD MSc, Study Director, University of Alberta
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