Anticoagulation Post Laparoscopic Splenectomy | NCT00769873

Studies
Anticoagulation Post Laparoscopic Splenectomy

NCT00769873

Sponsor

University of Alberta

Status

Terminated

Last Update Posted

Jun 24, 2009Estimated

Enrollment

35Actual

Phase

Phase 2

Conditions

Portal Vein Thrombosis
Splenic Vein Thrombosis

Interventions

Enoxaparin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment was slower than anticipated. Insufficient funding to expand to multi-centered trial.

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Apr 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Oct 8, 2008

First Submission Date that Met QC Criteria

Oct 8, 2008

First Posted Date

Oct 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2009

Last Update Posted Date

Jun 24, 2009Estimated

Name	Class
Edmonton Civic Employees Research Fund	OTHER
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Enoxaparin	Drug	Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days	Lovenox

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of portal/splenic vein thrombosis post laparoscopic splenectomy		three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospital		Edmonton	Alberta	T6G 2B7	Canada
Grey Nuns Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11919306	Background	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.
15286956	Background

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

ID	Term
D017984	Enoxaparin
D006495	Heparin, Low-Molecular-Weight