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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GUALTIERO PALARETI, St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT00362947
First received: August 11, 2006
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Thrombophlebitis
Drug: LMWH parnaparin subcutaneously
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis

Resource links provided by NLM:


Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • Primary effectiveness objectives [ Time Frame: 33 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Secondary effectiveness objectives [ Time Frame: 93 ] [ Designated as safety issue: No ]
    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.

  • secondary outcome for safety [ Time Frame: 33 ] [ Designated as safety issue: Yes ]
    the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).


Enrollment: 664
Study Start Date: August 2006
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
A - Parnaparin 8.500 UI aXa od (therapeutic doses) for 10 days followed by placebo for 20 days
Active Comparator: B
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
Active Comparator: C
C - Parnaparin 4.250 UI aXa od (prophylactic doses) for 30 days
Drug: LMWH parnaparin subcutaneously

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362947

Locations
Italy
Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi
Bologna, BO, Italy, 40138
U.O. Medicina Critica
Piacenza, PC, Italy, 29100
Sponsors and Collaborators
St. Orsola Hospital
Investigators
Study Chair: Gualtiero Palareti, MD University of Bologna
Principal Investigator: Benilde Cosmi, MD PhD University of Bologna
  More Information

No publications provided

Responsible Party: GUALTIERO PALARETI, Prof.Gualtiero Palareti, St. Orsola Hospital
ClinicalTrials.gov Identifier: NCT00362947     History of Changes
Other Study ID Numbers: The Steflux study
Study First Received: August 11, 2006
Last Updated: August 31, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by St. Orsola Hospital:
Superficial vein thrombosis
thrombophlebitis
LMWH
parnaparin

Additional relevant MeSH terms:
Thrombophlebitis
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014