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Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement

Primary Purpose

Thromboembolism, Arthroplasty Replacement, Knee

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Bilateral ultrasound examination 7+/- 2 after surgery
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring TKR, Ultrasonography, asymptomatic deep venous thrombosis, extended duration prophylaxis, short duration prophylaxis

Eligibility Criteria

46 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: First total knee joint replacement Signed informed consent Non-inclusion Criteria: History of venous thromboembolism/major bleeding/Heparin induced thrombopenia Active cancer Long-term anticoagulation

Sites / Locations

  • Hospital Alençon
  • Hospital University Angers
  • Clinique du Cèdre
  • Caen University hospital
  • Clinique St Marie
  • Hospital Val D'ariège
  • Hospital La Roche sur Yon
  • Mignot Hospital
  • Polyclinique de Riaumont
  • Hospital University Lille
  • Hospital Nord Mayenne
  • Montluçon Hospital
  • Poitiers University Hospital
  • Reims University Hospital
  • Clinique St André
  • Clinique St Jean
  • Clinique St Jean Languedoc

Outcomes

Primary Outcome Measures

Thromboembolism occuring between day 7-35 ;
Major bleeding occuring between day 7-35 ;
LMWH induced thrombopenia
All cause mortality

Secondary Outcome Measures

Full Information

First Posted
August 9, 2006
Last Updated
October 27, 2010
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT00362492
Brief Title
Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement
Official Title
9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Caen

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Arthroplasty Replacement, Knee
Keywords
TKR, Ultrasonography, asymptomatic deep venous thrombosis, extended duration prophylaxis, short duration prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Bilateral ultrasound examination 7+/- 2 after surgery
Primary Outcome Measure Information:
Title
Thromboembolism occuring between day 7-35 ;
Title
Major bleeding occuring between day 7-35 ;
Title
LMWH induced thrombopenia
Title
All cause mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First total knee joint replacement Signed informed consent Non-inclusion Criteria: History of venous thromboembolism/major bleeding/Heparin induced thrombopenia Active cancer Long-term anticoagulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Thérèse Barrellier, MD
Organizational Affiliation
Côte de Nacre University hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claude Vielpeau, MD
Organizational Affiliation
Côte de Nacre University hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Alençon
City
Alençon
ZIP/Postal Code
61014
Country
France
Facility Name
Hospital University Angers
City
Angers
Country
France
Facility Name
Clinique du Cèdre
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Facility Name
Caen University hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Clinique St Marie
City
Chalons sur Saone
ZIP/Postal Code
71100
Country
France
Facility Name
Hospital Val D'ariège
City
Foix
ZIP/Postal Code
0941
Country
France
Facility Name
Hospital La Roche sur Yon
City
La Roche sur Yon
ZIP/Postal Code
85295
Country
France
Facility Name
Mignot Hospital
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Polyclinique de Riaumont
City
Lievin
ZIP/Postal Code
62800
Country
France
Facility Name
Hospital University Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hospital Nord Mayenne
City
Mayenne
Country
France
Facility Name
Montluçon Hospital
City
Montluçon
ZIP/Postal Code
03100
Country
France
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Reims University Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Clinique St André
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Clinique St Jean
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Clinique St Jean Languedoc
City
Toulouse
ZIP/Postal Code
31077
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20797774
Citation
Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.
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Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement

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