PROLONG Study: Difference between revisions

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Revision as of 16:14, 25 September 2013

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

Official Title

D-Dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized “Prolong” Study

Objective

The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation. The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients.

Sponsor

St. Orsola Hospital

Timeline

Timeline
Start Date	September 2002
End Date	Not provided
Status	Completed

The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00264277.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase 4
Study Design
Allocation	Randomised
Endpoint	Safety/Efficacy Study
Interventional Model	Parallel Assignment
Masking	Open Label
Study Details
Primary Purpose	Treatment
Condition	Deep Vein Thrombosis Pulmonary Embolism
Intervention	Vitamin K antagonist (Coumarin anticoagulants)
Study Arms	Not provided
Population Size	600

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

Eligibility Criteria

Inclusion Criteria

Age > 18 years
After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
After at least 3 months of oral anticoagulation
After written informed consent

Exclusion Criteria

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

@@ Line 5: / Line 5: @@
 ==Official Title==
+D-Dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized “Prolong” Study
 ==Objective==
+The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain.  The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.  The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients.
 ==Sponsor==
+St. Orsola Hospital
 ==Timeline==
 {| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
@@ Line 17: / Line 17: @@
 | Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
 |-
-| Style="width:30%"| '''Start Date'''||Style="width:70%"|
+| Style="width:30%"| '''Start Date'''||Style="width:70%"| September 2002
-|-
-| '''Run-In Period'''||
 |-
-| '''End Date'''||
+| '''End Date'''||Not provided
 |-
-| '''Status'''||
+| '''Status'''||Completed
 |-
 |}
-<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/25/2013 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 NCT00264277.</span>
 ==Study Description==
@@ Line 34: / Line 32: @@
 | 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
 |-
-| '''Study Phase''' ||
+| '''Study Phase''' ||Phase 4
 |-
 | Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
 |-
-| '''Allocation'''||
+| '''Allocation'''||Randomised
 |-
-| '''Endpoint'''||
+| '''Endpoint'''|| Safety/Efficacy Study
 |-
-| '''Interventional Model'''||
+| '''Interventional Model'''||Parallel Assignment
 |-
-| '''Masking'''||
+| '''Masking'''||Open Label
 |-
 | Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
 |-
-| '''Primary Purpose'''||
+| '''Primary Purpose'''||Treatment
 |-
-| '''Condition'''||
+| '''Condition'''||Deep Vein Thrombosis<br>Pulmonary Embolism
 |-
-| '''Intervention'''||
+| '''Intervention'''||Vitamin K antagonist (Coumarin anticoagulants)
 |-
-| '''Study Arms'''||
+| '''Study Arms'''||Not provided
 |-
-| '''Population Size'''||
+| '''Population Size'''||600
 |-
 |}
@@ Line 66: / Line 64: @@
 ==Eligibility Criteria==
 ===Inclusion Criteria===
+*Age > 18 years
+*After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
+*After at least 3 months of oral anticoagulation
+*After written informed consent
+===Exclusion Criteria===
+*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
-===Exclusion Criteria===
 ==Outcomes==