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

NCT00362947 | Completed Phase 3 DMC

• 1 other identifier: The Steflux study
• Study Type: interventional
• Target: 664
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Thrombophlebitis

Keywords

Superficial vein thrombosis; thrombophlebitis; LMWH; parnaparin

Outcome Measures

Primary Outcomes (2)

• Primary effectiveness objectives

  composite of symptomatic and asymptomatic DVT, relapse and/or symptomatic or asymptomatic local extension of SVT and symptomatic PE at 33 days.

  33 days

• Major bleeding

  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.

  33

Secondary Outcomes (2)

• Secondary effectiveness objectives

  93

• secondary outcome for safety

  33

Study Arms (3)

A

PLACEBO COMPARATOR

A - Parnaparin 8.500 UI aXa od (therapeutic doses) for 10 days followed by placebo for 20 days

Drug: LMWH parnaparin subcutaneously

B

ACTIVE COMPARATOR

B - Parnaparin 8.500 UI aXa od for 10 days followed by 6.400 UI aXa once daily (intermediate therapeutic doses) for 20 days

Drug: LMWH parnaparin subcutaneously

C

ACTIVE COMPARATOR

C - Parnaparin 4.250 UI aXa od (prophylactic doses) for 30 days

Drug: LMWH parnaparin subcutaneously

Interventions

LMWH parnaparin subcutaneously DRUG

A; B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight \> 50 kg and less than 110 kg
• SVT of the grand saphenous vein for at least 4 cm
• SVT of the small saphenous vein for at least 4 cm
• Collateral SVT of the large saphenous vein of the thigh for at least 4cm

You may not qualify if:

• SVT of the grand saphenous vein reaching the saphenofemoral cross (within 3 cm)
• SVT of the small saphenous vein reaching the saphenopopliteal cross
• Documented proximal or distal DVT or pulmonary embolism
• SVT secondary to sclerotherapy
• Pregnancy and puerperium
• uncontrolled arterial hypertension (Systolic pressure \> 180 mmHg and diastolic pressure \> 110 mmHg)
• Active peptic ulcer
• Bacterial endocarditis
• Stroke in the previous 3 months
• Haemorrhagic diathesis
• Thrombocytopenia (platelets \< 100,000/ µL)
• Hypersensitivity to heparin or history of thrombocytopenia induced by heparin
• Creatinine \> 2 mg% (\> 180 µmol/L)
• Heparin therapy (any dose) or anticoagulant therapy for longer than the previous 72 hours
• In-hospital development of SVT

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

U.O. Medicina Critica

Piacenza, PC, 29100, Italy

Location

MeSH Terms

Conditions

Thrombophlebitis

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Phlebitis; Peripheral Vascular Diseases; Vasculitis

Study Officials

• Gualtiero Palareti, MD

  University of Bologna

  STUDY CHAIR

• Benilde Cosmi, MD PhD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Gualtiero Palareti

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)