Bobbio‐Pallavicini 1997.

Methods	Country: Italy Recruitment: Multicentre, Italian Cooperative Group Random allocation: Yes Blinding ‐ subjects: No ‐ assessors: No ‐ therapists: No Eligibility criteria for participants: Yes Baseline comparability of groups: yes Intention‐to‐treat analysis: NS Follow‐up: 100% (60 months)
Participants	Inclusion criteria Adults with TTP (platelet count < 100 x 109/L, microangiopathic haemolytic anaemia, high lactate dehydrogenase, low haptoglobin) Age (mean ± SD) Males: 39.6 ± 15.4 years Females: 37.3 ± 15.7 years Sex (M/F): 25/47 Treatment group Number: 35 Control group Number: 37
Interventions	Treatment group PE: 7 to 10 sessions, with at least 7 sessions in the first 10 days Methylprednisolone (2 mg/kg/d IV) Acetylsalicylic acid or lysine salicylate Dypyridamole (3 mg/kg/d orally or 0.4 mg/kg/d IV) Control group PE plus methylprednisolone Assessment of disease status at 15 days Patients who achieved full remission were treated with APT (ticlopidine (500 mg/d) for 1 year). Patients who achieved partial remission were scheduled to receive 7 more PEs and, if complete remission was not achieved, were given high dose IgG (0.4 g/kg/d, for 5 days). If complete remission was still not achieved, patients were treated as non‐responders (given salvage treatment of choice: vincristine, PGI2, high‐dose IgG, or splenectomy) Placebo: no
Outcomes	Failure of remission at 2 weeks Failure of remission at 1 month All‐cause mortality Relapse rate Disease status at 15 days: Complete remission: (platelets >150 x 109/L, reticulocytes < 100 x 109/L, LDH < 300 U/L, serum BUN < 50 mg% and creatinine 1.2 mg%)
Notes	TTP study
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate