Anticoagulation Post Laparoscopic Splenectomy

Phase 2

Terminated

• Conditions: Portal Vein Thrombosis; Splenic Vein Thrombosis
• Interventions: Drug: Enoxaparin

• Registration Number: NCT00769873
• Lead Sponsor: University of Alberta

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lovenox	Enoxaparin	Patients receive Lovenox 40mg SC daily (30mg SC daily if creatinine clearance \< 30) for 21 days after laparoscopic splenectomy

Primary Outcome Measures

Name	Time	Method
The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy	three years

Trial Locations

Locations (2)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Grey Nuns Hospital; 🇨🇦 Edmonton, Alberta, Canada