Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03297359
Eligibility Criteria:
Inclusion Criteria:
1. Known pathologically-confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin),
2. Confirmed symptomatic or incidental deep vein thrombosis requiring treatment, or confirmed symptomatic or incidental pulmonary embolism of a segmental or larger pulmonary artery,
3. Weight \> 90 kg,
4. Age ≥18 years,
5. Hemoglobin ≥ 80 g/L,
6. Able and willing to comply with study procedures and follow-up examinations contained within the written consent form.
Exclusion Criteria:
1. Acute VTE managed with thrombectomy, insertion of an inferior vena cava filter or with the use of thrombolytic agents,
2. More than 72 hours pre-treatment with therapeutic dosage of other LMWH, direct oral anticoagulants or vitamin K antagonists prior to enrolment to manage the current VTE event (unless the participant has been treated with weight-adjusted doses of commercial dalteparin in consistency with the dosing regime outlined in the protocol up to Day 7 visit \[±2 days\]),
3. Contraindication to heparin therapy:
1. history of heparin induced thrombocytopenia (HIT) as reported by patient,
2. platelet count of less than 50 x 109/L,
3. actively bleeding,
4. reported history of severe uncontrolled hypertension,
5. documented peptic ulcer within 6 weeks,
6. reported history of severe hepatic failure,
7. creatinine clearance of \< 30 ml/min as calculated by the Cockcroft-Gault formula,
8. heparin allergy,
9. Other contraindication to anticoagulation.
4. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or 4 at the time of study enrolment,
5. Life expectancy \< 1 month,
6. Women of childbearing age without proper contraceptive measures and women who are pregnant or breast feeding,
7. Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor),
8. Unable/unwilling to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03297359
Study Brief:
Protocol Section:
NCT03297359