Anticoagulation Post Laparoscopic Splenectomy

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Anticoagulation in Reducing the Incidence of Splenic/Portal Vein Thrombosis Post-Laparoscopic Splenectomy Protocol Number: 5698

Conditions
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Portal Vein Thrombosis, Splenic Vein Thrombosis

Intervention / Treatment
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* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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® Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lovenox<br>Patients receive Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days after laparoscopic splenectomy | Drug: Enoxaparin<br>* Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days<br>* Other names: Low molecular weight heparin;|
| No Intervention: No Lovenox<br>Patients do NOT receive Lovenox post laparoscopic splenectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy |  | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulation, thrombosis, portal vein thrombosis, splenic vein thrombosis, splenectomy, randomized, laparoscopic splenectomy, lovenox