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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

LMWH parnaparin subcutaneously

About this trial

This is an interventional treatment trial for Thrombophlebitis focused on measuring Superficial vein thrombosis, thrombophlebitis, LMWH, parnaparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi
U.O. Medicina Critica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

secondary outcome for safety

the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).

Full Information

NCT ID

NCT00362947

First Posted

August 11, 2006

Last Updated

March 18, 2021

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT00362947

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombophlebitis

Keywords

Superficial vein thrombosis, thrombophlebitis, LMWH, parnaparin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

664 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

B

Arm Type

Active Comparator

Arm Description

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

Arm Title

C

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

LMWH parnaparin subcutaneously

Primary Outcome Measure Information:

Title

Primary effectiveness objectives

Description

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

Time Frame

33 days

Title

Major bleeding

Description

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.

Time Frame

33

Secondary Outcome Measure Information:

Title

Secondary effectiveness objectives

Description

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.

Time Frame

93

Title

secondary outcome for safety

Description

the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).

Time Frame

33

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gualtiero Palareti, MD

Organizational Affiliation

University of Bologna

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Benilde Cosmi, MD PhD

Organizational Affiliation

University of Bologna

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bologna

State/Province

BO

ZIP/Postal Code

40138

Country

Italy

Facility Name

U.O. Medicina Critica

City

Piacenza

State/Province

PC

ZIP/Postal Code

29100

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

No

Thrombophlebitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial