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:
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00428441
First received: January 26, 2007
Last updated: August 18, 2011
Last verified: August 2011
Results First Received: August 18, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

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

5.  Secondary:   Mortality   [ Time Frame: 3 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
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  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
Study First Received: January 26, 2007
Results First Received: August 18, 2011
Last Updated: August 18, 2011
Health Authority: Italy: Ethics Committee