N/A
Completed N=102
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
Acute Deep Vein Thrombosis
Source: ClinicalTrials.gov NCT00480636 ↗
Enrolled (actual)
102
Serious AEs
12.8%
Results posted
Aug 2010
Primary outcomePrimary: Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg — 43 Participants
Summary
To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg |
43 | — |
| SECONDARY Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood |
— | — |
| SECONDARY Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) |
— | — |
| SECONDARY Percent of Participants With and Without Pulmonary Embolism (PE) |
15.7; 80.4; 3.9; 6.9; 83.3; 9.8 | — |
| SECONDARY Number of Participants With Recurrent DVT |
3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00480636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.