VAPRED Study: Difference between revisions

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==Official Title==
==Official Title==
 
Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation


==Objective==
==Objective==
 
The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation


==Sponsor==
==Sponsor==
 
University Hospital, Grenoble
==Timeline==
==Timeline==
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
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| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
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| Style="width:30%"| '''Start Date'''||Style="width:70%"|  
| Style="width:30%"| '''Start Date'''||Style="width:70%"| March 2005
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| '''Run-In Period'''||
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| '''End Date'''||
| '''End Date'''||May 2010
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| '''Status'''||
| '''Status'''||phase 4
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|-
|}
|}
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT------.</span>
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .</span>


==Study Description==
==Study Description==
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description'''
|-
|-
| Style="width:30%"|'''Study Type'''|| Style="width:70%"|
| Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional
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|-
| '''Study Phase''' ||
| '''Study Phase''' ||Phase 4
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|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
|-
|-
| '''Allocation'''||
| '''Allocation'''||Non-Randomized
|-
|-
| '''Endpoint'''||
| '''Endpoint'''|| Safety Study
|-
|-
| '''Interventional Model'''||
| '''Interventional Model'''||Single Group Assignment
|-
|-
| '''Masking'''||
| '''Masking'''|| Open Label
|-
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
|-
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| '''Primary Purpose'''||
| '''Primary Purpose'''||Prevention
|-
|-
| '''Condition'''||
| '''Condition'''||Previous Vka Treatment<br>Previous Proximal VTE
|-
|-
| '''Intervention'''||
| '''Intervention'''||Echo Doppler (ED), DDimers and phone follow up<br>ED score, DDimers level and phone questionnary
|-
|-
| '''Study Arms'''||
| '''Study Arms'''||Follow up<br>ED score and DDimer level of patients who have stopped their VKA treatment (after the first or the second previous proximal VTE).<br>Phone follow up for 2 years.<br>Intervention: Other: ED, DDimers and phone follow up
|-
|-
| '''Population Size'''||
| '''Population Size'''||222
|-
|-
|}
|}


<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT-----.</span>
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .</span>


==Eligibility Criteria==
==Eligibility Criteria==
===Inclusion Criteria===
===Inclusion Criteria===
 
*>18 and <80 years old
*First or second treated proximal VTE event (+/- Pulmonary embolism)
*Signed informed consent
 
===Exclusion Criteria===
===Exclusion Criteria===
*Active cancer or currently treated
*Previous VTE>2
*Long term anticoagulant treatment for VTE diseases
*Long term anticoagulant treatment for other diseases
*Pregnancy, parturient or breast feeding
*Person deprived of freedom by judicial or administrative decision
*Consent unsigned


==Outcomes==
==Outcomes==
===Primary Outcomes===
===Primary Outcomes===
 
VTE event recurrence [ Time Frame: 0-2 years ] [ Designated as safety issue: Yes ]
===Secondary Outcomes===
===Secondary Outcomes===
Not provided


==Publications==
==Publications==

Latest revision as of 19:14, 25 September 2013

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Official Title

Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation

Objective

The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation

University Hospital, Grenoble

Timeline

Timeline
Start Date March 2005
End Date May 2010
Status phase 4

The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .

Study Description

Study Description
Study Type Interventional
Study Phase Phase 4
Study Design
Allocation Non-Randomized
Endpoint Safety Study
Interventional Model Single Group Assignment
Masking Open Label
Study Details
Primary Purpose Prevention
Condition Previous Vka Treatment
Previous Proximal VTE
Intervention Echo Doppler (ED), DDimers and phone follow up
ED score, DDimers level and phone questionnary
Study Arms Follow up
ED score and DDimer level of patients who have stopped their VKA treatment (after the first or the second previous proximal VTE).
Phone follow up for 2 years.
Intervention: Other: ED, DDimers and phone follow up
Population Size 222

The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .

Eligibility Criteria

Inclusion Criteria

  • >18 and <80 years old
  • First or second treated proximal VTE event (+/- Pulmonary embolism)
  • Signed informed consent

Exclusion Criteria

  • Active cancer or currently treated
  • Previous VTE>2
  • Long term anticoagulant treatment for VTE diseases
  • Long term anticoagulant treatment for other diseases
  • Pregnancy, parturient or breast feeding
  • Person deprived of freedom by judicial or administrative decision
  • Consent unsigned

Outcomes

Primary Outcomes

VTE event recurrence [ Time Frame: 0-2 years ] [ Designated as safety issue: Yes ]

Secondary Outcomes

Not provided

Publications

Results

Conclusion

References

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