No registrations found.
ID
Source
Brief title
Health condition
post-thrombotic syndrome (posttrombotisch syndroom), compression therapy (compressietherapie), elastic stockings (elastische kousen), venous insufficiency (veneuze insufficientie), deep venous thrombosis (diep veneuze trombose)
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The incidence of post-thrombotic syndrome in the second year of compression therapy.
Secondary outcome
- Evaluation of duplex ultrasound after one year compression therapy as predictive marker for PTS.
- Evaluation of baseline characteristics as predictive markers for PTS.
- Evaluation of quality of life (QoL)
Background summary
Prospective single-blind study to the optimal duration of ambulant compression therapy (ACT) after deep venous thrombosis as prevention of the post-thrombotic syndrome. After one year of ACT patients are randomized to either continuing ACT for a following year or stopping therapy. At inclusion, a blind duplex ultrasound is performed to evaluate its predictive value in PTS, as well as evaluation of baseline characteristics and laboratory findings. Quality of Life assessment is done at inclusion and after one year follow-up.
Study objective
We hypothesise that one year compression therapy after DVT is equally effective as two years in the prevention of the post-thrombotic syndrome - in selected patients.
Study design
T=0 randomization, duplex ultrasound, QoL
T=3 follow-up PTS (phone interview)
T=6 follow-up PTS (outpatient clinic)
T=12 follow-up PTS (outpatient clinic), QoL
Intervention
At inclusion, patients will be randomized in two groups; one receiving a following year of compression therapy, one without.
G.C. Mol
Bosboomstraat 1
Utrecht 3582 KE
The Netherlands
+31 (0)30 2566566
GMol@diakonessenhuis.nl
G.C. Mol
Bosboomstraat 1
Utrecht 3582 KE
The Netherlands
+31 (0)30 2566566
GMol@diakonessenhuis.nl
Inclusion criteria
1. All patients with deep venous thrombosis who received one year of compression therapy.
Exclusion criteria
1. Recurrent ipsilateral DVT
2. Contra indication for (stopping) compression therapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1381 |
| NTR-old | NTR1442 |
| Other | : 0801-60 Fonds NutsOhra |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |