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Portal Vein ThrombosisPhase 2NCT00769873

Anticoagulation Post Laparoscopic Splenectomy

A Phase 2 study testing Enoxaparin in people with Portal Vein Thrombosis and Splenic Vein Thrombosis, run by University of Alberta at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesCanada
Study dates
Oct 2006to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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®

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Grey Nuns Hospital

    Edmonton, Alberta, T6L 5X8

Other trials in Canada

About this study

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

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.

Being tested
Enoxaparin
Keywords
anticoagulation, thrombosis, portal vein thrombosis, splenic vein thrombosis, splenectomy, randomized, laparoscopic splenectomy, lovenox
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnoxaparinDrug

    Also called Low molecular weight heparin

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

Study groups in NCT00769873
Study groupRoleWhat they receive
LovenoxActive comparatorPatients receive Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days after laparoscopic splenectomy
Receives: Drug: Enoxaparin
No LovenoxNo interventionPatients do NOT receive Lovenox post laparoscopic splenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2008 (estimated)
  2. Study startOct 2006
  3. Primary completionApr 2009
  4. Study completionMay 2009

Why it stopped: Recruitment was slower than anticipated. Insufficient funding to expand to multi-centered trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00769873
Sponsor's protocol ID
5698
Status last verified
Jun 2009
First submitted
8 Oct 2008
Last updated
24 Jun 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11919306

  • 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.

    PubMed 15286956

  • 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.

    PubMed 9747171

  • 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.

    PubMed 9278651

  • 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.

    PubMed 14627254

  • 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.

    PubMed 15383478

  • 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.

    PubMed 11442521

  • 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.

    PubMed 8259430

  • 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.

    PubMed 10971433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enoxaparin in people with Portal Vein Thrombosis and Splenic Vein Thrombosis, run by University of Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment was slower than anticipated. Insufficient funding to expand to multi-centered trial.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy (time frame: three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00769873, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2009.

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