Dialysis Access Consortium (DAC) Manual of Operations Graft Study Dialysis Access Consortium MANUAL OF OPERATIONS Graft Study (3/15/06) 1. RECRUITMENT ..............................................................................................................................1 1.1 Purpose.......................................................................................................................................1 1.2 Keys to recruitment....................................................................................................................1 1.3 Target population.......................................................................................................................1 1.4 Early notification.......................................................................................................................1 1.5 Referral pattern leading to vascular access placement ..............................................................1 1.6 Identification of potential study participants .............................................................................2 1.7 Recruitment steps.......................................................................................................................2 2. ENROLLMENT ...............................................................................................................................3 2.1 Purpose.......................................................................................................................................3 2.2 Components ...............................................................................................................................3 2.3 Who does the enrollment ...........................................................................................................3 2.4 When and where will enrollment take place..............................................................................4 2.5 When should enrollment be completed......................................................................................4 2.6 Required personnel training.......................................................................................................4 2.7 Training and certification...........................................................................................................4 2.8 Detailed description of each of the three major components of the enrollment phase (informed consent, screening and baseline data). ......................................................................4 2.8.1 Informed consent......................................................................................................................4 2.8.1.1 Purpose..............................................................................................................................4 2.8.1.2 Obtaining the consent.......................................................................................................5 2.8.1.3 Details to be covered in obtaining the informed consent document.................................5 2.8.2 Screening data (DAC study form 311) ...................................................................................11 2.8.2.1 Purpose............................................................................................................................11 2.8.2.2 Inclusion criteria.............................................................................................................11 Graft Template Consent......................................................................................................................14 2.8.2.3 Exclusion criteria............................................................................................................23 2.8.3 Baseline data...........................................................................................................................27 2.8.3.1 Purpose............................................................................................................................27 2.8.3.2 Obtaining the baseline data.............................................................................................27 2.8.3.3 Recording the baseline data ............................................................................................28 2.8.3.4 Collecting specimen for DNA and blood repository ......................................................32 2.8.3.5 Detailed Procedures for Shipping Specimens.................................................................34 Appendix 1..........................................................................................................................................35 Appendix 2..........................................................................................................................................36 Appendix 3..........................................................................................................................................38 3. RANDOMIZATION.......................................................................................................................41 3.1 Purpose.....................................................................................................................................41 3.2 Steps in randomization.............................................................................................................41 4. STUDY TREATMENT PLAN.......................................................................................................44 i 4.1 Study visits...............................................................................................................................44 4.1.1 Purpose....................................................................................................................................44 4.1.2 Frequency of the study visits ..................................................................................................44 4.1.3 Duration of study visits...........................................................................................................44 4.1.4 Who does the study visits .......................................................................................................44 4.1.5 Location of the study visits.....................................................................................................45 4.2 Study drug administration........................................................................................................45 4.2.1 Study drug...............................................................................................................................45 4.2.2.1 How to release the study treatment assignment..............................................................46 4.3 Bleeding ...................................................................................................................................47 4.3.1 Classification of bleeding .......................................................................................................47 4.3.2 Surgery or other invasive procedures .....................................................................................47 4.3.2.1 Elective surgery..............................................................................................................47 4.3.2.2 Emergent surgery with high adverse risk of bleeding ....................................................47 4.3.3 Other adverse events...............................................................................................................47 4.3.3.1 Headaches and diarrhea ..................................................................................................47 4.3.4 Concomitant medications........................................................................................................48 4.3.4.1 Contraindicated medications...........................................................................................48 4.3.4.2 Rationale .........................................................................................................................48 4.4 Study completion .....................................................................................................................49 Appendix: Unmasking Physicians List...................................................................................................50 5. FLOW MONITORING..................................................................................................................53 5.1 Rationale ..................................................................................................................................53 5.2 Who does the flow monitoring?...............................................................................................53 5.3 Where is the flow monitoring done?........................................................................................53 5.4 Time table for flow monitoring................................................................................................53 5.4.1 The first flow measurement ....................................................................................................53 5.4.2 The second flow measurement................................................................................................53 5.4.3 Repeat a critical flow measurement........................................................................................53 5.4.4 One flow measurement after the primary endpoint ................................................................54