search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


DUET II


- candidate number25470
- NTR NumberNTR6194
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2016
- Secondary IDsNL49466.100.15 
- Public TitleDUET II
- Scientific TitleDutch randomized trial comparing Ultrasound-accelerated thrombolysis with standard dose Urokinase versus half dose Urokinase for thrombo-embolic infra-inguinal arterial disease
- ACRONYMDUET II
- hypothesisHalf dose Urokinase (50.000IE/h) will significantly reduce hemorrhagic complications compared with the standard dose Urokinase (100.000IE/h) with comparable technical success rate
- Healt Condition(s) or Problem(s) studiedThrombus formation
- Inclusion criteria1. Patients with acute and sub-acute (less than 7 weeks) thrombosed infra-inguinal native arteries with ischemic complaints.
2. Patients with acute and sub-acute (less than 7 weeks) thrombosed infra-inguinal venous or prosthetic bypass grafts with ischemic complaints.
3. Limb ischemia class I and IIa according to the Rutherford classification (see below).
4. Patients >18 years and <85 years old.
5. Patients understand the nature of the procedure and provide written informed consent, prior to enrolment in the study
- Exclusion criteria1. Patients with isolated common femoral artery thrombosis including the origin of the superficial femoral artery and/ or profunda femoral artery
2. Patients with clinical complaints of lower limb ischemia due to thrombosis of femoro-popliteal or femoro-crural native arteries or femoro-popliteal and femoro-crural bypass grafts >7 weeks
3. Patients with acute lower limb ischemia class IIb and III according to the Rutherford classification (see below)
4. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
5. Recent (< 6 weeks) ischemic stroke or cerebral bleeding
6. Patients with recent (<6 weeks) surgery
7. Severe hypertension (diastolic blood pressure >110 mmHg, systolic blood pressure >200 mmHg)
8. Current malignancy
9. Patients with a history of prior life-threatening contrast medium reaction
10. Patients with uncorrected bleeding disorders (GI ulcera, mennorrhagia, liver failure)
11. Female patients of child bearing age not taking adequate contraceptives or currently breastfeeding
12. Pregnancy
13. Any patient considered being hemodynamically unstable at onset of procedure
14. Patients refusing treatment
15. Patients currently participating in another investigational drug or device study that have not completed the entire follow up period
16. Patients < 18 years or >85 years old
17. Severe co-morbid condition with life expectancy < 1 month
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate
- Target number of participants124
- Interventions50.000IE/h Urokinase
100.000IE/h Urokinase
- Primary outcomeOccurrence of hemorrhagic complications.
- Secondary outcome1. Technical success defined as >95% lysis of thrombosed native artery or bypass within 48 hours
2. Duration of successful catheter-derived thrombolysis needed for uninterrupted flow in the thrombosed arterial segment with outflow via at least one crural artery.
3. Units Urokinase needed for technical success.
4. Distal thrombo-embolic complications
- TimepointsFollow up visit will be 30 days after treatment
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdrs. I.M. van Dop
- CONTACT for SCIENTIFIC QUERIESdrs. I.M. van Dop
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Sint Antonius Ziekenhuis Nieuwegein
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD28-okt-2016 - 19-feb-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl