Iron Deficiency, Platelet Phenotype and Thromboembolism in Cancer Patients

INTERVENTION: Trade Name: Ferinject Product Name: ferric carboxymaltose Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ferric carboxymaltose CAS Number: 9007‐72‐01 Current Sponsor code: Vifor int Other descriptive name: ferinject Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: colorectal cancer, iron deficiency ; MedDRA version: 16.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 16.0 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 10027433 ‐ Metabolism and nutrition disorders Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To evaluate the effect of iron therapy on platelet counts in patients with colorectal cancer and iron deficiency Primary end point(s): drop in platelet counts>10% Secondary Objective: To evaluate the effect of iron therapy on platelet activity and growth factors in patients with colorectal cancer and iron deficiency Timepoint(s) of evaluation of this end point: week 2 SECONDARY OUTCOME: Secondary end point(s): platelet activation, platelet aggregation, p‐selectin, TPO, EPO, Interleukin‐6/3/11 Timepoint(s) of evaluation of this end point: week 2 INCLUSION CRITERIA: newly diagnosed colorectal cancer iron deficiency 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 84 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range