NCT00362947

Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis

Completed Phase 3 Last updated 18 March 2021

What this trial tests

Phase 3 trial testing LMWH parnaparin subcutaneously in Thrombophlebitis in 664 participants. Completed in 1 February 2011.

Timeline

1 August 2006

Primary endpoint
1 September 2010

1 February 2011

Quick facts

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	664
Start date	1 August 2006
Primary completion	1 September 2010
Estimated completion	1 February 2011
Sites	2 locations across Italy

Drugs / interventions tested

• LMWH parnaparin subcutaneously — full drug profile →

Conditions studied

• Thrombophlebitis — all drugs for Thrombophlebitis →

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

18 and older, any sex, with Thrombophlebitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Primary effectiveness objectives
  Time frame: 33 days
  composite of symptomatic and asymptomatic DVT, relapse and/or symptomatic or asymptomatic local extension of SVT and symptomatic PE at 33 days.
• Major bleeding
  Time frame: 33
  Bleeding events were defined as major if retroperitoneal, intracranial, intraocular with severe vision damage, intra-articular, intra-abdominal of upper or lower digestive tract, genito-urinary tract, respiratory tract or associated with a decrease in the haemoglobin of ≥ 2.0 g/dL, or if requiring transfusion of ≥2 units of blood or if fatal. Bleeding was classified as minor in all other cases.

Sponsor's own description

The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. This study aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more effective than a prophylactic dose and also to assess whether 10 rather than 30 days are sufficient for treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.