TropicALL study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23171

Enrollment

354

Registered

2014-07-30

Start date

2014-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TropicALL, ALL, Acute Lymphoblastic Leukemia, Thromboprophylaxis, Children Low-molecur-weight heparin, venous thrombosis. TropicALL, ALL, Acute Lymfoblastische Leukemie, tromboprofylaxe, kinderen, laag-moleculair-gewicht heparine (LMWH), veneuze trombose

Interventions

In the intervention arm, high prophylactic dose LMWH (nadroparin) is subcutaneously injected daily, adjusted to actual body weight with 85 IU anti-Xa/kg with a maximum of 5700 IU anti-Xa daily. Target

Eligibility

Inclusion criteria

Inclusion criteria: All patients between 1 and 19 years of age with primary ALL, who are eligible for and treated within the DCOG ALL-11 or 12 study protocol.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Incidence of symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm.	—

Secondary

Measure	Time frame
1. Incidence of the composite of major bleeding or clinically relevant non-major bleeding in the intervention and standard arm; 2. Incidence of composite of asymptomatic and symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm. 3. ALL treatment outcomes by assessment of complete remission and (overall or disease-free) survival rates in the intervention and standard arm; 4. Identification of clinical risk factors and hematological biomarkers in consecutively included patients with and without VTE; to increase insight in the pathogenesis of coagulation disorders during ALL treatment, and to establish a risk model for VTE	—

Measure

Time frame

1. Incidence of the composite of major bleeding or clinically relevant non-major bleeding in the intervention and standard arm; 2. Incidence of composite of asymptomatic and symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm. 3. ALL treatment outcomes by assessment of complete remission and (overall or disease-free) survival rates in the intervention and standard arm; 4. Identification of clinical risk factors and hematological biomarkers in consecutively included patients with and without VTE; to increase insight in the pathogenesis of coagulation disorders during ALL treatment, and to establish a risk model for VTE

—

Contacts

Public ContactCH Ommen, van

Erasmus MC

c.vanommen@erasmusmc.nl010 7036691

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)