Catheter-directed Venous Thrombolysis in acute iliofemoral vein thrombosis--the CaVenT study: rationale and design of a multicenter, randomized, controlled, clinical trial (NCT00251771).
BACKGROUND
The conventional treatment of acute deep vein thrombosis (DVT) is anticoagulation and compression therapy, as recommended in the international guidelines. Anticoagulation prevents recurrent venous thrombosis, pulmonary embolism, and death. Compression therapy reduces the risk of developing long-term sequelae, that is, postthrombotic syndrome (PTS). Evaluation of systemic thrombolysis has shown effective thrombolysis and a likely reduction in PTS but at the cost of increased risk of bleeding complications. Catheter-directed thrombolysis (CDT) was introduced for rapid removal of thrombi and salvage of venous valves with less systemic thrombolytic effect, and is being offered to selected patients with iliofemoral DVT to prevent development of PTS. Case series have shown technical and thrombolytic success; however, no randomized studies have evaluated the long-term clinical effects of venous CDT. The aim of the CaVenT study is to investigate the role of adjunctive CDT by evaluating its clinical efficacy and safety compared with conventional treatment alone in patients with acute iliofemoral DVT.


METHODS
The CaVenT study is an open, randomized, controlled, clinical trial. We plan to include 200 patients who will receive either CDT, in addition to conventional treatment, or conventional treatment alone. The primary outcome measures are patency at 6 months and prevalence of PTS at 2 years.


CONCLUSIONS
Implementation of the CaVenT study will be a contribution toward evidence-based medicine in the treatment of acute proximal DVT of the leg. Any documentation of improved functional outcome will have a significant impact on clinical practice for this patient group and may lead to a modification of existing international guidelines.
Enden
Tone
T
Department of Hematology, Ullevål University Hosp, Oslo, Norway. tone.enden@medisin.uio.no
Sandvik
Leiv
L
Kløw
Nils-Einar
NE
Hafsahl
Geir
G
Holme
Pål Andre
PA
Holmen
Lars Olaf
LO
Ghanima
Waleed
W
Njaastad
Anne Mette
AM
Sandbaek
Gunnar
G
Slagsvold
Carl-Erik
CE
Sandset
Per Morten
PM
D000293:Adolescent; D000328:Adult; D000368:Aged; D002406:Catheterization, Peripheral / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005268:Femoral Vein; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D005500:Follow-Up Studies; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage*; D006801:Humans; D007084:Iliac Vein; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010690:Phlebography; D012189:Retrospective Studies; D055502:Secondary Prevention; D015912:Thrombolytic Therapy / Q000379:methods*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D016896:Treatment Outcome; D014463:Ultrasonography; D020246:Venous Thrombosis / Q000000981:diagnostic imaging / Q000188:drug therapy*
D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D010959:Tissue Plasminogen Activator