Title

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

    Phase 2
  • Study Type

    Interventional
  • Status

    Terminated
  • Intervention/Treatment

    enoxaparin ...
  • Study Participants

    35
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 Started
Oct 31
2006
Primary Completion
Apr 30
2009
Study Completion
May 31
2009
Last Update
Jun 24
2009
Estimate

Drug Enoxaparin

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

  • Other names: Low molecular weight heparin

Lovenox Active Comparator

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

No Lovenox No Intervention

Patients do NOT receive Lovenox post laparoscopic splenectomy

Criteria

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
No Results Posted