Status:
TERMINATED
Anticoagulation Post Laparoscopic Splenectomy
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Edmonton Civic Employees Research Fund
Sanofi
Conditions:
Portal Vein Thrombosis
Splenic Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00769873
Start Date
October 1 2006
End Date
May 1 2009
Last Update
June 24 2009
Active Locations (2)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
Grey Nuns Hospital
Edmonton, Alberta, Canada, T6L 5X8