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

Thrombophlebitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362947
• Other study ID #: The Steflux study
• Status: Completed
• Phase: Phase 3
• Start date: August 2006
• Est. completion date: February 2011

Study information

• Verified date: March 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Outpatients with an episode of SVT of the grand saphenous vein (for at least 4 cm), and/or SVT of the small saphenous vein (for at least 4 cm), and/or SVT of a collateral vein of the large saphenous vein of the thigh (for at least 4cm) are included in this prospective, randomised, double blind, national multicentre study.

Patients will be randomised into double-blind groups to receive (syringes will be identical in appearance) in consecutively numbered boxes:

A - Parnaparin, dose of 8,500 IU aXa taken subcutaneously once a day for 10 days B - Parnaparin, dose of 8,500 IU aXa per day for 10 days followed by Parnaparin 6,400 IU aXa per day for the subsequent three weeks. C - Parnaparin, dose of 4,250 IU aXa per day for 30 days Elastic compression treatment will be recommended with special stocking and/or elastic bandaging with compression to the ankles of 20-40 mmHg, where not contraindicated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: February 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Previous saphenectomy by any method

• Surgery in the previous 30 days

• Serious liver disease

• Use of dextran, mannitol, thrombolytic treatment, chronic use of NSAID and cortisone-based drugs.

• Active cancer or under chemotherapy or radiotherapy

• Thrombectomy of superficial vein involved

• Refusal to give informed consent

Related Conditions & MeSH terms

• Thrombophlebitis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• LMWH parnaparin subcutaneously

Locations

Country	Name	City	State
Italy	Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi	Bologna	BO
Italy	U.O. Medicina Critica	Piacenza	PC

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Secondary effectiveness objectives	i)- reduction in local symptoms during treatment and ii)- the combined efficacy end-point during a follow-up of 93 days after the start of treatment.	93
Secondary	secondary outcome for safety	the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).	33