Accidental extravasation of anthracyclines MedDRA version: 7.1 Level: pref Classification code 10022062
Conditions
Interventions
Product Name: Savene
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Dexrazoxane
CAS Number: 24584-09-6
Concentration unit: mg milligram(s)
Concentration number:
Sponsors
TopoTarget A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cancer patients in chemotherapy with anthracyclines 2. Extravasation (leakage) of anthracycline suspected according to: a) a primary assessment by the physician b) presence of at least one of the following symptoms - pain, swelling, or redness at the site where the anthracycline leakage is suspected to have occured OR suspicion of anthracycline extravasation from a central venous access device 3. The Savene treatment must be started within 6 hours after the accident 4. Age more or equal to 18 years 5. Performance status 2 or less 6. Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known allergy towards dexrazoxane 2. reasonable suspision of extravasation of other vesicant compounds than anthracyclines through the same intravenous access 3. AST or ALT, bilirubin, alkaline phosphatase > 3 x upper normal value 4. WBC < or equal to 1.5 x 1o 9/L and platelets < or equal to 75 x 10 9/L 5. Administration of dexrazoxane within the last 3 weeks or administration of other extravasation treatments than those described in the protocol 6. Pregnant or breast feeding women 7. Women of childbearing age and potential, who do not use an efficient contraceptive (such as oral contraception, IUD intrauterine device, depot of gestagen, vaginal hormone ring or transdermal depot patch) for at least 7 days after the dexrazoxane treatment. A pregnancy test should be performed on day 1, if possible by a dipstick method to be read immediately. However, treatment should not be delayed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine pharmakokinetic parameter during the 3-day Savene treatment;Secondary Objective: To observe the efficacy of Savene treatment To evaluate safety issues of the Savene tretment;Primary end point(s): Obtainment of a pharmacokinetic profile for the three-day Savene The prevention of: surgical intervention due to the extravasation incident and/or necrosis due to the event late sequelae postponement of planned cytostatic treatment | — |
Countries
Denmark
Outcome results
None listed