DRKS00000218.

Trial name or title	GRANITE Transfusion of granulocytes for patients with febrile neutropenia
Methods	Parallel multi‐centre randomised controlled trial in Germany Planned recruitment 100 participants
Participants	Inclusion Criteria People aged between 1 and 75 years of age With one of the following diseases: acute myeloid leukaemia, acute lymphoblastic leukaemia, chronic myeloid leukaemia, chronic lymphatic leukaemia, myelodysplastic syndrome, unspecified, chronic myeloproliferative disease, follicular (nodular) non‐Hodgkin's lymphoma diffuse non‐Hodgkin's lymphoma peripheral T‐cell lymphoma Multiple myeloma Hodgkin's lymphoma Who have: Karnofsky Performance Status > 20% Echocardiography ejection‐fraction > 40% Creatinine clearance > 60mL/min Oxygen saturation at least 80% Therapy‐refractory fever above 38°C without response to standard‐therapy for 96 hours Exclusion Criteria Symptomatic coronary heart disease Cardiac insufficiency NYHA III or IV Lung disease with dyspnoea WHO III or IV Oxygen saturation < 80% Severe therapy‐refractory arterial hypertension Non‐therapy‐induced neutropenia (e.g. aplastic anaemia) Active psychiatric disease Severe kidney‐dysfunction (creatinine‐clearance < 60 mL/min) Severe hepatic‐dysfunction with bilirubin > 2 mg/dL Insufficient therapy of a thyroid‐dysfunction (T3/T4 out of the reference range) Pregnancy or lactation Noncontrollable life‐threatening bleeding Intracerebral process leading to an increase of intracranial pressure (bleeding, infectious disease, tumour) Cerebral convulsions Karnofsky Performance Status < 20% Participation in the clinical trial in the last 30 days Medical or psychiatric condition, which does not allow the patient to participate in the clinical trial
Interventions	Arm 1: Intervention‐group: Transfusion of standardised apheresis‐products of granulocytes on every other day/alternating days + standard‐therapy (antibiotics/antimycotics) Arm 2: Control‐group: standard‐therapy without transfusion of granulocytes
Outcomes	Primary outcome Measurement of temperature (auricularly or orally); Intervention group: 1h before, at starting time and ending of the transfusion of granulocytes, 1h, 12h and 24h after the transfusion. Control group: 0h (equates to 1h before the transfusion in the intervention group), 12h and 24h Endpoint: the normalisation of the temperature (measurement intraauricular or oral; <38°C) for 72h Secondary outcomes End of neutropenia (not as a consequence of transfusions); Value of neutrophil granulocytes in a blood sample > 500/μL on two following days in an upward trend
Starting date	Study has not yet opened to recruitment
Contact information	Contact for Public or Scientific Queries Mr. Prof. Dr. med. Kai Hübel Klinik I für Innere Medizin Universitätsklinikum Köln Kerpener Str. 62 50937 Köln Germany e‐mail: kai.huebel at uni‐koeln.de Mr. Dr. med. Maximilian Fresen Klinik I für Innere Medizin Universitätsklinikum Köln Kerpener Str. 62 50937 Köln Germany e‐mail: Maximilian.Fresen at uk‐koeln.de
Notes	Recruitment locations University Medical Center Klinik I für Innere Medizin, Köln University Medical Center Klinik für Innere Medizin, Hannover University Medical Center Klinik für Pädiatrie, Hannover Funding Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.) Sponsor Universität zu Köln Albertus‐Magnus‐Platz 50923 Köln Germany Uni‐Köln‐478 (Prüfplancode) Ethics Committee 10‐103 , Ethik‐Kommission der Medizinischen Fakultät der Universität zu Köln Trial registrations DRKS‐ID: DRKS00000218 Universal Trial Number (UTN): U1111‐1111‐9560 EudraCT‐No. (for studies acc. to Drug Law): 2009‐010700‐28

NYHA: New York Heart Association
 WHO: World Health Organization