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D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism

This study has been terminated.
(Enrolment was halted prematurely because of the observed excess in recurrences)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428441
First Posted: January 30, 2007
Last Update Posted: September 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria
Results First Submitted: August 18, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Venous Thromboembolism
Intervention: Drug: Warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment period 2007-2009 location Thrombosis centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
D-dimer Negative patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment

Participant Flow:   Overall Study
    D-dimer Negative
STARTED   75 
COMPLETED   74 
NOT COMPLETED   1 
Lost to Follow-up                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
D-dimer Negative patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment

Baseline Measures
   D-dimer Negative 
Overall Participants Analyzed 
[Units: Participants]
 75 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   43 
>=65 years   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.9  (14) 
Gender 
[Units: Participants]
 
Female   34 
Male   41 
Region of Enrollment 
[Units: Participants]
 
Italy   75 


  Outcome Measures

1.  Primary:   Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels   [ Time Frame: 1 year ]

2.  Primary:   Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Mortality   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Walter Ageno
Organization: University of Insubria
phone: +39 0332 278831
e-mail: agewal@yahoo.com


Publications:

Responsible Party: Walter Ageno, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT00428441     History of Changes
Other Study ID Numbers: 2175
First Submitted: January 26, 2007
First Posted: January 30, 2007
Results First Submitted: August 18, 2011
Results First Posted: September 26, 2011
Last Update Posted: September 26, 2011