ACT reduces the incidence of PTS after DVT. In the Dutch CBO-guidelines current therapy is adviced for 2 years after diagnosis because most PTS develops within 2 years after DVT, with a peak incidence in the first year.Some clinicians claim that one…
ID
Source
Brief title
Condition
- Skin vascular abnormalities
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
- The incidence of PTS in the second post-thrombotic year after one versus two
years of ambulant compression therapy
Secondary outcome
Secundary outcomes:
- Can venous ultrasound discriminate between patients after one year ACT in
risk of developing PTS
- Can baseline characteristics be used as prognostic markers for developing PTS
- What influence does (the absense of) ACT and PTS has on quality of life
Background summary
In the past years much research is done to diagnostic and therapeutic aspects
of deep vein thrombosis (DVT) and one of its major complications, the
post-thrombotic syndrome (PTS). The clinical presentation of PTS can vary from
mild oedema with little complaints to severe swelling of the leg with chronic
pain and in the worst case even ulceration. Above that, PTS has a negative
influence on quality of life and has social economic consequences for patient
and the health care system. Ambulant compression therapy (ACT) has proven to
significantly decrease the incidence of PTS. Few research has been done to te
optimal duration of ACT or factors that help predict this.
Study objective
ACT reduces the incidence of PTS after DVT. In the Dutch CBO-guidelines current
therapy is adviced for 2 years after diagnosis because most PTS develops within
2 years after DVT, with a peak incidence in the first year.
Some clinicians claim that one year ACT may be evenly effective, but there's no
scientific evidence yet to confirm that. Also patient characteristics may
influence the risk of developing PTS, such as age, gender, BMI, thrombus
location or venous insufficiency.
Main objective of the study is to evaluate optimal duration of ACT after DVT
and to assess risk factors for PTS.
Study design
The study is designed as prospective, single blind, randomised, multicenter
trial. All patients aged 18y and older with ultrasound proven proximal DVT of
the leg are eligible for inclusion. One year after diagnosis subjects are
randomised into two groups: 1) continuing ACT for another year; 2) no ACT in
second year post-DVT. For secondary outcomes echo duplex and laboratory samples
are taken at baseline. Also quality-of-life assessment and compliance is
measured for all study subjects. Follow up is set to 15 months: twice telephone
interview and two visits to the outpatient clinic.
Intervention
Two groups:
1) continuing ACT for another year; 2) no ACT in second year post-DVT.
Study burden and risks
Burden:
- 20cc of blood is drawn (once)
- once duplex ultrasound of the leg
- phone interview at T=3 en T=15 months
- three times outpatient clinic at T=0, 6 and 12 months
Risks:
- hardly any risks
(see protocol for more information (in Dutch))
Bosboomstraat 1
3582 KE Utrecht
NL
Bosboomstraat 1
3582 KE Utrecht
NL
Listed location countries
Age
Inclusion criteria
all patients with one year adequate therapy after echo duplex proven proximal DVT of the leg
informed consent
Exclusion criteria
recurrent ipsilateral DVT (known riskfactor of PTS)
PTS developped in first year post-thrombosis
DVT only distal of popliteal vein
contra-indication for (stopping) compression therapy as indicated by treating physician
no informed consent
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL25244.100.08 |
| Other | NTR1442, Ned.Trialregister |