Clinical trial · Observational
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)
NCT00480636CI-TRIAL-00003762completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Deep Vein Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fragmin (dalteparin sodium ) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- One cohort of patients treated with dalteparin.
- description
- About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study.
- interventionNames
- Drug: Fragmin (dalteparin sodium )
Primary outcomes (1)
- measure
- Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
- timeFrame
- Month 6 or End of Treatment (EOT) (up to Month 6)
- description
- Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
Secondary outcomes (4)
- measure
- Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
- timeFrame
- Baseline through Month 6 or EOT (up to Month 6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patient of 18 - 70 years of age. * Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung. Exclusion Criteria: * Bleeding * Hypersensitivity to FRAGMIN® or other low-molecular weight heparins. * Serum creatinine level \> 150 umol/l. * Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy. * Patient on oral anticoagulation therapy in the last 7 days.
References
Publications (0)
Data not yet available
No reference posted for this study.