NCT01809054

Brief Summary

This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:

  1. 1.Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
  2. 2.Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

April 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

March 8, 2013

Results QC Date

March 18, 2014

Last Update Submit

March 18, 2014

Conditions

Primary Total Hip and Knee Arthroplasty

Keywords

Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss

Outcome Measures

Primary Outcomes (1)

  • Blood Loss

    requiring transfusion

    6 weeks

Secondary Outcomes (1)

  • Deep Vein Thrombosis

    6 weeks

Study Arms (2)

Arixtra Arm

ACTIVE COMPARATOR

Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks

Drug: ArixtraDrug: Aspirin

Pneumatic compression stockings arm

ACTIVE COMPARATOR

Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Device: Pneumatic compression stockingsDrug: Aspirin

Interventions

ArixtraDRUG
Arixtra Arm
Pneumatic compression stockingsDEVICE

Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)

Pneumatic compression stockings arm
AspirinDRUG
Arixtra ArmPneumatic compression stockings arm

Eligibility Criteria

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

You may qualify if:

  • Men or women age ≥ 18 years old
  • Total knee or total hip arthroplasty planned in the 60 days following study enrollment

You may not qualify if:

  • Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
  • History of bleeding diathesis
  • Known active malignancy
  • Prothrombin time \>1.5 x control
  • Platelet count \< 100,000/mm3, hematocrit \< 30%, creatinine clearance \<30 mL/min
  • Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis
  • Major surgery within past 3 months of enrollment
  • Patients requiring bilateral arthroplasty
  • Body weight \<50 kg (venous thromboembolism prophylaxis only)
  • Unable to return to site for follow-up visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Sinai Center for Thrombosis Research

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

FondaparinuxIntermittent Pneumatic Compression DevicesAspirin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydratesEquipment and SuppliesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Kevin Bliden
Organization
Sinai Center for Thrombosis Research
kbliden@lifebridgehealth.org
4106014795

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 12, 2013

Study Start

April 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 21, 2014

Results First Posted

April 21, 2014

Record last verified: 2014-03

Locations

US(2)