Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670432
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2020-11-20
Brief Title:
Resolution Enhancement by a Supplemental Obstruction Lessening Venoactive Drug for Eight Weeks in Deep Vein Thrombosis
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Resolution Enhancement by a Supplemental Obstruction Lessening Venoactive Drug for Eight Weeks in Deep Vein Thrombosis A Pilot Study to Evaluate if Hydroxyethylrutoside Reduces the Risk of Post-Thrombotic Syndrome in Patients With DVT
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Resolve-DVT
Brief Summary:
The RESOLVE-DVT study is a randomized single-center pilot study to determine the effects of hydroxyethylrutoside Venoruton on aspects of deep vein thrombosis DVT resolution associated with post-thrombotic syndrome PTS Based on these results the investigators will estimate its potential as a preventive therapy for PTS
Eligible consenting patients who develop an acute objectively confirmed DVT will be randomized and equally allocated to two trial arms either the treatment group Venoruton tablet 500 mg twice daily or the control group usual care The pilot trial consists of 5 study contacts over 12 weeks at which outcome assessment is performed inclusion 1 week 4 weeks 8 weeks 12 weeks Treatment allocation is masked for outcome assessors but not for patients
Eligible consenting patients who develop an acute objectively confirmed DVT will be randomized and equally allocated to two trial arms either the treatment group Venoruton tablet 500 mg twice daily or the control group usual care The pilot trial consists of 5 study contacts over 12 weeks at which outcome assessment is performed inclusion 1 week 4 weeks 8 weeks 12 weeks Treatment allocation is masked for outcome assessors but not for patients
Detailed Description:
Rationale After a DVT one in three patients develops PTS of the affected leg despite anticoagulant treatment and elastic compression therapy ECT in the acute phase of DVT Considering the major societal burden associated with PTS supplementation of current prevention with an effective pharmacotherapeutic therapy would be of high value Since the pathogenesis of PTS is mediated through persistent inflammation during thrombus resolution causing damage to the vein wall resulting in venous insufficiency the venoactive flavonoids with their vasoprotective and anti-inflammatory properties provide an excellent candidate As investigational medicinal product the highly effective flavonoid Hydroxyethylrutoside Venoruton was chosen
Objective To assess the effect of Venoruton on PTS-associated aspects of DVT resolution
Study design A single-center randomized controlled pilot study
Study population Adults presenting themselves at the emergency department ED with a first acute proximal DVT of the lower extremity Inclusion will be performed within 48 hours after diagnosis of DVT
Intervention Administration of 500 mg Venoruton twice daily for 8 weeks following DVT in addition to standard treatment by ECT and anticoagulant therapy
Baseline characteristics Assessments include demographic data smoking status site and extension of DVT side of affected leg duration of complaints at time of diagnosis risk factors for DVT immobilisation trauma etc type of ECT presencesuspicion of pulmonary embolism concomitant medications
Main study parameters The primary study outcome is residual vein obstruction RVO assessed by duplex ultrasound DUS at 12 weeks after DVT Main secondary outcomes are levels of circulating biomarkers and severity of PTS-characterizing clinical signs at baseline 1 week 4 weeks 8 weeks and 12 weeks Moreover we measure quality of life QoL and PTS-characterizing symptoms at baseline 4 weeks and 12 weeks
Additional study parameters Medication adherence and ECT compliance at 1 week 4 weeks 8 weeks and 12 weeks Pill count of Venoruton at 8 weeks Pill count of direct oral anticoagulant DOAC at 12 weeks The occurrence of relevant serious adverse events is assessed at all visits
Nature and extent of the burden and risks associated with participation benefit and group relatedness Patients have a follow-up duration of 12 weeks after diagnosis of DVT In addition to their visit at the ED patients will visit the outpatient clinic four times during follow-up At each visit secondary outcomes are measured through questionnaires blood withdrawal and assessment of the affected leg The first visit coincides with inclusion and two subsequent visits 4 and 12 weeks coincide with the regular clinical care pathway The primary outcome RVO is measured at 12 weeks after DVT by DUS Patients allocated to the intervention group will take two oral tablets daily over a period of eight weeks Venoruton has been established as safe with rarely occurring mild reversible side-effects through many years of experience
Masking while patients are aware of their treatment allocation the physicians and researchers are not as to provide unbiased outcome assessment
Objective To assess the effect of Venoruton on PTS-associated aspects of DVT resolution
Study design A single-center randomized controlled pilot study
Study population Adults presenting themselves at the emergency department ED with a first acute proximal DVT of the lower extremity Inclusion will be performed within 48 hours after diagnosis of DVT
Intervention Administration of 500 mg Venoruton twice daily for 8 weeks following DVT in addition to standard treatment by ECT and anticoagulant therapy
Baseline characteristics Assessments include demographic data smoking status site and extension of DVT side of affected leg duration of complaints at time of diagnosis risk factors for DVT immobilisation trauma etc type of ECT presencesuspicion of pulmonary embolism concomitant medications
Main study parameters The primary study outcome is residual vein obstruction RVO assessed by duplex ultrasound DUS at 12 weeks after DVT Main secondary outcomes are levels of circulating biomarkers and severity of PTS-characterizing clinical signs at baseline 1 week 4 weeks 8 weeks and 12 weeks Moreover we measure quality of life QoL and PTS-characterizing symptoms at baseline 4 weeks and 12 weeks
Additional study parameters Medication adherence and ECT compliance at 1 week 4 weeks 8 weeks and 12 weeks Pill count of Venoruton at 8 weeks Pill count of direct oral anticoagulant DOAC at 12 weeks The occurrence of relevant serious adverse events is assessed at all visits
Nature and extent of the burden and risks associated with participation benefit and group relatedness Patients have a follow-up duration of 12 weeks after diagnosis of DVT In addition to their visit at the ED patients will visit the outpatient clinic four times during follow-up At each visit secondary outcomes are measured through questionnaires blood withdrawal and assessment of the affected leg The first visit coincides with inclusion and two subsequent visits 4 and 12 weeks coincide with the regular clinical care pathway The primary outcome RVO is measured at 12 weeks after DVT by DUS Patients allocated to the intervention group will take two oral tablets daily over a period of eight weeks Venoruton has been established as safe with rarely occurring mild reversible side-effects through many years of experience
Masking while patients are aware of their treatment allocation the physicians and researchers are not as to provide unbiased outcome assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None