Trial Outcomes & Findings for D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism (NCT NCT00428441)

Results Overview

Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

1 year

Results posted on

2011-09-26

Participant Flow

recruitment period 2007-2009 location Thrombosis centers

Participant milestones

Participant milestones
Measure	D-dimer Negative patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
Overall Study STARTED	75
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	D-dimer Negative patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-dimer Negative n=75 Participants patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Age Continuous	61.9 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment Italy	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis

Outcome measures

Outcome measures
Measure	D-dimer Negative n=75 Participants patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels	9 participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

Adverse Events

D-dimer Negative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Walter Ageno

University of Insubria

Phone: +39 0332 278831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place