NCT00769873

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

2.5 years

First QC Date

October 8, 2008

Last Update Submit

June 23, 2009

Conditions

Portal Vein ThrombosisSplenic Vein Thrombosis

Keywords

anticoagulationthrombosisportal vein thrombosissplenic vein thrombosissplenectomyrandomizedlaparoscopic splenectomylovenox

Outcome Measures

Primary Outcomes (1)

  • The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy

    three years

Study Arms (2)

Lovenox

ACTIVE COMPARATOR

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

Drug: Enoxaparin

No Lovenox

NO INTERVENTION

Patients do NOT receive Lovenox post laparoscopic splenectomy

Interventions

EnoxaparinDRUG

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

Also known as: Low molecular weight heparin
Lovenox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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®

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Grey Nuns Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Related Publications (9)

  • Bergqvist D, Agnelli G, Cohen AT, Eldor A, Nilsson PE, Le Moigne-Amrani A, Dietrich-Neto F; ENOXACAN II Investigators. Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer. N Engl J Med. 2002 Mar 28;346(13):975-80. doi: 10.1056/NEJMoa012385.

    PMID: 11919306BACKGROUND

  • Bergqvist D. Low molecular weight heparin for the prevention of venous thromboembolism after abdominal surgery. Br J Surg. 2004 Aug;91(8):965-74. doi: 10.1002/bjs.4639.

    PMID: 15286956BACKGROUND

  • Chaffanjon PC, Brichon PY, Ranchoup Y, Gressin R, Sotto JJ. Portal vein thrombosis following splenectomy for hematologic disease: prospective study with Doppler color flow imaging. World J Surg. 1998 Oct;22(10):1082-6. doi: 10.1007/s002689900521.

    PMID: 9747171BACKGROUND

  • Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery: a double-blind randomized multicentre trial with venographic assessment. ENOXACAN Study Group. Br J Surg. 1997 Aug;84(8):1099-103.

    PMID: 9278651BACKGROUND

  • Fujita F, Lyass S, Otsuka K, Giordano L, Rosenbaum DL, Khalili TM, Phillips EH. Portal vein thrombosis following splenectomy: identification of risk factors. Am Surg. 2003 Nov;69(11):951-6.

    PMID: 14627254BACKGROUND

  • Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.

    PMID: 15383478BACKGROUND

  • Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.

    PMID: 11442521BACKGROUND

  • Petit P, Bret PM, Atri M, Hreno A, Casola G, Gianfelice D. Splenic vein thrombosis after splenectomy: frequency and role of imaging. Radiology. 1994 Jan;190(1):65-8. doi: 10.1148/radiology.190.1.8259430.

    PMID: 8259430BACKGROUND

  • van't Riet M, Burger JW, van Muiswinkel JM, Kazemier G, Schipperus MR, Bonjer HJ. Diagnosis and treatment of portal vein thrombosis following splenectomy. Br J Surg. 2000 Sep;87(9):1229-33. doi: 10.1046/j.1365-2168.2000.01514.x.

    PMID: 10971433BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

EnoxaparinHeparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • James Shapiro, MD PhD FRCS(Eng)

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Haili Wang, MD FRCSC

    University of Alberta

    STUDY DIRECTOR

  • Daniel Kopac, MD MSc

    University of Alberta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

October 1, 2006

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

CA(2)