Anticoagulation Post Laparoscopic Splenectomy

This study has been terminated.
(Recruitment was slower than anticipated. Insufficient funding to expand to multi-centered trial.)
Sponsor:
Collaborators:
Edmonton Civic Employees Research Fund
Sanofi
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00769873
First received: October 8, 2008
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Portal Vein Thrombosis
Splenic Vein Thrombosis
Drug: Enoxaparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: October 2006
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Enoxaparin
  • Low molecular weight heparin
No Intervention: No Lovenox
Patients do NOT receive Lovenox post laparoscopic splenectomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769873

Locations
Canada, Alberta
Grey Nuns Hospital
Edmonton, Alberta, Canada, T6L 5X8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Edmonton Civic Employees Research Fund
Sanofi
Investigators
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
  More Information

Publications:

Responsible Party: Dr. James Shapiro, University of Alberta
ClinicalTrials.gov Identifier: NCT00769873     History of Changes
Other Study ID Numbers: 5698
Study First Received: October 8, 2008
Last Updated: June 23, 2009
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Cardiovascular Diseases
Vascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014