Anticoagulation Post Laparoscopic Splenectomy

University of Alberta

Status and phase

Terminated

Phase 2

Conditions

Splenic Vein Thrombosis

Portal Vein Thrombosis

Treatments

Drug: Enoxaparin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00769873

5698

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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