Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis
15. januar 2017 opdateret af: Qianxin Huang, Xuzhou Medical University
Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis
The purpose of this study is to determine whether the novel aspiration thrombectomy device combined with catheter-directed thrombolysis is effective in the treatment of acute iliofemoral deep venous thrombosis (IF-DVT).
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Catheter-directed thrombolysis will be performed in eligible patients with acute IF-DVT.
A combined mechanical thrombectomy will be used to clear the iliac thrombi in experimental group.
The immediate, mid- and long-term outcomes will be recorded.
Quantitative data wiil be expressed as mean ± SD, and will be compared with independent-sample t-test or paired-sample t-test.
Count data will be expressed as a ratio (or percentage), and the chi-square test or the fisher's exact test will be used for comparisons.
A difference with P < 0.05 will be considered statistically significant.
All statistical analyses will be performed using IBM SPSS, version 22.0 (SPSS Inc., Chicago, IL, USA).
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Jiangsu
-
Xuzhou, Jiangsu, Kina, 221006
- Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of iliofemoral deep venous thrombosis
- Symptoms of less than 14 days' duration
- With good function status
- A life expectancy of more than 1 year
- A low risk of bleeding
Exclusion Criteria:
- Without iliac vein thrombosis
- Anticoagulation and/or thrombolysis contraindications
- Systemic infection
- Heart, hepatic, renal function insufficiency
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Combined thrombectomy device
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis.
Ten million U of urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy.
Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge
|
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
catheter-directed thrombolysis will be used in both arms
anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge
Andre navne:
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
Andre navne:
|
|
Andet: Catheter-directed thrombolysis
Participants will undergo catheter-directed thrombolysis alone.
A total of 100,000 units urokinase will be pulse-spray injected through the catheter once every 4-6 h.
Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge
|
catheter-directed thrombolysis will be used in both arms
anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge
Andre navne:
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
patency of lower extremity deep venous
Tidsramme: up to 36 months
|
participants will be followed for the duration of hospital stay and will be followed for up to 36 months by lower limb vein color Doppler ultrasonography
|
up to 36 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
technical success rate
Tidsramme: intraoperation
|
The ratio of successful and total number of participants
|
intraoperation
|
|
thrombus removal rate
Tidsramme: intraoperation
|
The ratio of preoperative and postoperative thrombosis amount
|
intraoperation
|
|
complications
Tidsramme: intraoperation
|
a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture
|
intraoperation
|
|
blood loss
Tidsramme: intraoperation
|
The volume of blood loss during operation will be recorded
|
intraoperation
|
|
improvement of clinical symptoms and signs
Tidsramme: up to 36 months
|
participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations
|
up to 36 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
incidence of postthrombotic syndrome
Tidsramme: up to 36 months
|
participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration
|
up to 36 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Qingqiao Zhang, PHD, Xuzhou Medical University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2014
Primær færdiggørelse (Forventet)
1. december 2017
Studieafslutning (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
25. marts 2015
Først indsendt, der opfyldte QC-kriterier
7. april 2015
Først opslået (Skøn)
13. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Embolisme og trombose
- Trombose
- Venøs trombose
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- Antikoagulanter
- Heparin
- Kalk
- Calcium heparin
- Heparin, lavmolekylær vægt
- Tinzaparin
- Dalteparin
- Calcium, diæt
Andre undersøgelses-id-numre
- BL2014030
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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