Anticoagulation Post Laparoscopic Splenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769873
Recruitment Status : Terminated (Recruitment was slower than anticipated. Insufficient funding to expand to multi-centered trial.)
First Posted : October 9, 2008
Last Update Posted : June 24, 2009
Edmonton Civic Employees Research Fund
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Splenic Vein Thrombosis Drug: Enoxaparin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Anticoagulation in Reducing the Incidence of Splenic/Portal Vein Thrombosis Post-Laparoscopic Splenectomy Protocol Number: 5698
Study Start Date : October 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lovenox
Patients receive Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days after laparoscopic splenectomy
Drug: Enoxaparin
Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days
Other Name: Low molecular weight heparin
No Intervention: No Lovenox
Patients do NOT receive Lovenox post laparoscopic splenectomy

Primary Outcome Measures :
  1. The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy [ Time Frame: three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00769873

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Grey Nuns Hospital
Edmonton, Alberta, Canada, T6L 5X8
Sponsors and Collaborators
University of Alberta
Edmonton Civic Employees Research Fund
Principal Investigator: James Shapiro, MD PhD FRCS(Eng) University of Alberta
Study Director: Haili Wang, MD FRCSC University of Alberta
Study Director: Daniel Kopac, MD MSc University of Alberta


Responsible Party: Dr. James Shapiro, University of Alberta Identifier: NCT00769873     History of Changes
Other Study ID Numbers: 5698
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009

Keywords provided by University of Alberta:
portal vein thrombosis
splenic vein thrombosis
laparoscopic splenectomy

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action