NCT00628576

Brief Summary

The purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 1993

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1993

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

March 5, 2008

Status Verified

February 1, 2008

Enrollment Period

10.7 years

First QC Date

February 25, 2008

Last Update Submit

February 26, 2008

Conditions

Deep Venous Thrombosis

Keywords

Deep Venous Thrombosislower extremitiesChronic Venous InsufficiencyPostthrombotic SyndromeHeparinsLow-molecular- weight heparinTinzaparin

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.

    Two years and 6 to 10 years

Study Arms (2)

1

ACTIVE COMPARATOR

UFH: patients treated with unfractionated heparin

Drug: unfractionated heparin

2

EXPERIMENTAL

FH: patients treated with low-molecular-weight (fractionated) heparin

Drug: Tinzaparin (Leo)

Interventions

unfractionated heparinDRUG

UFH: Continuous i.v. infusion 100 IU/kg/4hrs initially and then adjusted to maintain APTT value 1.5 - 2.5 the pre-treatment value

Also known as: Heparin SAD 1000 IU/ml
1
Tinzaparin (Leo)DRUG

FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily

Also known as: Innohep (Leo)
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First DVT with or without known risk factors except overt cancer
  • Second DVT more than two years after the first if the patient was without clinical signs of CVI.

You may not qualify if:

  • Contraindication to anticoagulation therapy
  • Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
  • Known cancer at the time of the DVT diagnosis
  • Patients unable to cooperate for anticoagulation therapy or manage the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Haematology; Aalborg Hospital

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Venous ThrombosisPostthrombotic Syndrome

Interventions

HeparinTinzaparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesHeparin, Low-Molecular-Weight

Study Officials

  • Benedicte Laursen, MD, DMSc

    Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

October 1, 1993

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

March 5, 2008

Record last verified: 2008-02

Locations

DK(1)