PROLONG-II Study: Difference between revisions

Jump to navigation Jump to search
VisualWikitext
(Created page with "__NOTOC__ {{D-dimer}} {{CMG}} ==Official Title== ==Objective== ==Sponsor== ==Timeline== {| class="wikitable" border="1" style="background:WhiteSmoke" width="40%" |- | C...")
 
No edit summary
Line 5: Line 5:


==Official Title==
==Official Title==
 
A Multicentre, Prospective, Observational Study on the Predictive Role for Recurrence of D-dimer Levels Measured During and After Anticoagulation in Patients With a First Venous Thromboembolism Episode (the PROLONG-II Study)


==Objective==
==Objective==
 
The Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up


==Sponsor==
==Sponsor==
 
St. Orsola Hospital
==Timeline==
==Timeline==
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
Line 17: Line 17:
| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
|-
|-
| Style="width:30%"| '''Start Date'''||Style="width:70%"|  
| Style="width:30%"| '''Start Date'''||Style="width:70%"| August 2005
|-
|-
| '''Run-In Period'''||
| '''End Date'''||June 2008
|-
|-
| '''End Date'''||
| '''Status'''||Completed
|-
| '''Status'''||
|-
|-
|}
|}
<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 09/20/2013 using the identification number NCT00266045</span>


==Study Description==
==Study Description==
Line 34: Line 32:
| 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%"|Observational
|-
|-
| '''Study Phase''' ||
| Style="width:30%"|'''Study Design'''|| Style="width:70%"|Observational Model: Cohort<br>Time Perspective: Prospective
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
|-
| '''Allocation'''||
|-
| '''Endpoint'''||
|-
| '''Interventional Model'''||
|-
| '''Masking'''||
|-
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
|-
|-
| '''Primary Purpose'''||
| '''Condition'''||Deep Vein Thrombosis<br>Pulmonary Embolism
|-
| '''Condition'''||
|-
| '''Intervention'''||
|-
|-
| '''Study Arms'''||
| '''Population Size'''||355
|-
| '''Population Size'''||
|-
|-
|}
|}


<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 09/20/2013 using the identification number NCT00266045.</span>


==Eligibility Criteria==
==Eligibility Criteria==
===Inclusion Criteria===
===Inclusion Criteria===
 
*Age > 18 years
*After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
*After at least 6 months of oral anticoagulation
*After written informed consent
===Exclusion Criteria===
===Exclusion Criteria===
*Age > 82 y
*Recurrent venous thromboembolism
*If the Venous thromboembolism occurred:
**during pregnancy or puerperium
**after recent (i.e. within three months) fracture or plaster casting of a leg,
**after immobilization with confinement to bed for three consecutive days after surgery with general anesthesia lasting longer than 30 minutes
*Patients with:
**active cancer
**antiphospholipid antibody syndrome
**antithrombin deficiency
**serious liver disease or renal insufficiency (creatininemia > 2 mg/dL),
**other indications for anticoagulation or contraindications for this treatment
**limited life expectation
*Patients who live too far from the clinical center


==Outcomes==
==Outcomes==

Revision as of 16:34, 25 September 2013

D-Dimer Microchapters

Home

Patient information

Overview

Historical Perspective

Physiology

Clinical Correlation

Causes of High D-dimer

Diagnostic Role in Thromboembolism

Prognostic Role in Mortality

Prognostic Role in Thromboembolism Occurence

Prognostic Role in Thromboembolism Recurrence

Prognostic Role in Non-Thromboembolism

Clinical Trials

Landmark Trials

Case #1

PROLONG-II Study On the Web

Most recent articles

Most cited articles

Review articles

CME Programs

Powerpoint slides

Images

American Roentgen Ray Society Images of PROLONG-II Study

All Images
X-rays
Echo & Ultrasound
CT Images
MRI

Ongoing Trials at Clinical Trials.gov

US National Guidelines Clearinghouse

NICE Guidance

FDA on PROLONG-II Study

CDC on PROLONG-II Study

PROLONG-II Study in the news

Blogs on PROLONG-II Study

Directions to Hospitals Treating D-dimer

Risk calculators and risk factors for PROLONG-II Study

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

Official Title

A Multicentre, Prospective, Observational Study on the Predictive Role for Recurrence of D-dimer Levels Measured During and After Anticoagulation in Patients With a First Venous Thromboembolism Episode (the PROLONG-II Study)

Objective

The Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up

St. Orsola Hospital

Timeline

Timeline
Start Date August 2005
End Date June 2008
Status Completed

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00266045

Study Description

Study Description
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Study Details
Condition Deep Vein Thrombosis
Pulmonary Embolism
Population Size 355

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00266045.

Eligibility Criteria

Inclusion Criteria

  • Age > 18 years
  • After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
  • After at least 6 months of oral anticoagulation
  • After written informed consent

Exclusion Criteria

  • Age > 82 y
  • Recurrent venous thromboembolism
  • If the Venous thromboembolism occurred:
    • during pregnancy or puerperium
    • after recent (i.e. within three months) fracture or plaster casting of a leg,
    • after immobilization with confinement to bed for three consecutive days after surgery with general anesthesia lasting longer than 30 minutes
  • Patients with:
    • active cancer
    • antiphospholipid antibody syndrome
    • antithrombin deficiency
    • serious liver disease or renal insufficiency (creatininemia > 2 mg/dL),
    • other indications for anticoagulation or contraindications for this treatment
    • limited life expectation
  • Patients who live too far from the clinical center

Outcomes

Primary Outcomes

Secondary Outcomes

Publications

Results

Conclusion

References

Template:WH Template:WS

Retrieved from "https://www.wikidoc.org/index.php?title=PROLONG-II_Study&oldid=907619"