Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00655122

Enrollment

Registered

2008-04-09

Start date

2003-04-30

Completion date

2003-12-31

Last updated

2008-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism, Deep Vein Thrombosis, Dalteparin

Brief summary

The primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects.

Detailed description

The study was prematurely terminated on December 9, 2003. The reason for the early termination was not related to a safety or efficacy issue. It was related to the difficulty in recruiting patients.

Interventions

DRUGDalteparin sodium

Dalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.

DRUGPlacebo

Placebo was administered with a daily injection of 0.2 mL by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 65 years * Confinement to bed for more than 3 days, due to: * Heart failure * Exacerbated chronic obstructive pulmonary disease * Acute rheumatic involvement * Written informed consent

Exclusion criteria

1. Cancer 2. Anticoagulant treatment in the previous 3 months 3. Stroke or major surgery in the previous 3 months 4. Systolic pressure \>200 mmHg or diastolic pressure \>120 mmHg 5. Known chronic hepatopathy 6. Active hemorrhage in any site in the previous 3 months 7. Active peptic ulcer 8. Bacterial endocarditis 9. Conditions that can increase the risk of hemorrhage 10. Known coagulation disorders 11. Hypersensitivity to heparin or HIT 12. Life expectancy of less than 3 months 13. Previous confinement to bed during more than 3 days

Design outcomes

Primary

Measure	Time frame
Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period.	1 month

Secondary

Measure	Time frame
Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.	1 month

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026