Skip to main content
. 2009 Jan 21;2009(1):CD003595. doi: 10.1002/14651858.CD003595.pub2

Henon 1992.

Methods Country: France 
 Recruitment: Multicentre 
 Randomisation: Central 
 Blinding 
 ‐ subjects: NS 
 ‐ assessors: NS 
 ‐ therapists: NS 
 Intention‐to‐treat analysis: No 
 Follow‐up: 100% (12 months)
Participants Inclusion criteria
  • Adults with TTP

  • 28 French natives, 9 natives of other Mediterranean countries.

  • Five patients with cancer (3 treated with mitomycin C and diagnosed with TTP)

  • 5 cases developed due to incorrect treatment with ticlopidine (3), aspirin (2) for venous thrombosis and 3 cases with cimetidine.

  • Pregnancy (2), oral contraceptives (8), tobacco (12), alcoholism (2). Only 37% patients presented with triad of haemorrhage, neurological symptoms, renal impairment. All patients however presented all eligibility criteria at some point in their clinical course.


Males/age: 14, median 35 years (range: 19‐62) 
 Females/age: 25, median 39 years (range: 18‐57)
Treatment group 
 Number: 19
Control group 
 Number: 19
Interventions Treatment group
  • Daily PE with FFP (15 mL/kg) in albumin (45 mL/kg) until complete remission achieved.


Control group
  • Daily transfusion of FFP (15 mL/kg) until complete remission achieved


Both groups received aspirin (10 mL/kg/d) plus dipyridamole (10 mg/kg/d). 
 If treatment or control failed, a common regime of PE with FFP (60 mL/kg/d) tried. After a second failure, salvage therapy (splenectomy, steroids, vincristine, infusion of PGI2), alone or in various combinations, could be tried
Outcomes
  • Failure of remission at 2 weeks

  • Failure of remission at 1 month

  • All‐cause mortality

  • Relapse rate

  • Complete remission (normalisation of clinical biochemical parameters)

Notes
  • TTP study

  • Post randomisation exclusions

    • 2 patients, 1 from treatment (due to death prior to treatment) and 1 from control group(due to wrong diagnosis)

Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear