TropicALL study; Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin: a randomized controlled trial

Dutch Childhood Oncology Group0 个研究点目标入组 354 人开始时间: 2014年11月4日最近更新: 2019年6月30日

试验速览

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•All patients between 1 and 19 years of age with primary ALL, who are eligible for and treated within the DCOG ALL-11 or ALL-12 study protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 354
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•a. Patients who are already being treated with anticoagulation upon screening (for other indications)
•b. Patients with a heparin allergy (or for one of its components), a recent history (within 6 months) of heparin-induced thrombocytopenia (HIT) or any other contraindication listed in the local labeling of LMWH
•c. Patients without informed consent
•d. Patients with active bleeding or high risk for bleeding contraindicating anticoagulant therapy (Thrombocytopenia is not an exclusion criterion)
•e. Patients with renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min/1.73m2)
•f. Patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
•g. Patients with stage 2 hypertension defined as blood pressure confirmed > 99th percentile + 5 mmHg
•h. Patients with any condition that, as judged by the investigator, would place the patient at increased risk of harm if he/she participated in the study.

发起方

Dutch Childhood Oncology Group