Clinical trial · Interventional
A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow enrollment and lack of continuing funds
Summary
Brief summary (as posted)
Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Embolism | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dalteparin injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High Risk for VTE recieving dalteparin
- description
- Patients assigned at random to receive prophylactic dalteparin injections
- interventionNames
- Drug: dalteparin injection
- type
- NO_INTERVENTION
- label
- High Risk for VTE No therapy
- description
- No prophylactic therapy for VTE prevention given (Subjects receiving standard of care)
- type
- NO_INTERVENTION
- label
- Low Risk for VTE
- description
- Used as a control for the secondary outcome of evaluating tissue factor in collected blood samples
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A histologic diagnosis of malignancy; * At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen); * A risk score for VTE ≥3 \[assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites\], hemoglobin \<10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count \> 11,000/mm3 or body mass index ≥ 35 kg/m2\]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable. * Age 18 years or older * Provide written, informed consent. Exclusion Criteria: * Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator * Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome * Planned stem cell transplant * Life expectancy \< 6 months * Known allergy to heparin or LMWH * Patient or caregiver incapable of daily self-injection * Acute or chronic renal insufficiency with creatinine clearance \< 30 mL/min * History of heparin-induced thrombocytopenia * Allergy to contrast agents * Pregnancy * Need for anticoagulant therapy * Platelet count \< 75,000/mm3
References
Publications (2)
- DERIVEDRutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5. PMID 33337539
- DERIVEDKhorana AA, Francis CW, Kuderer NM, Carrier M, Ortel TL, Wun T, Rubens D, Hobbs S, Iyer R, Peterson D, Baran A, Kaproth-Joslin K, Lyman GH. Dalteparin thromboprophylaxis in cancer patients at high risk for venous thromboembolism: A randomized trial. Thromb Res. 2017 Mar;151:89-95. doi: 10.1016/j.thromres.2017.01.009. Epub 2017 Jan 26. PMID 28139259