Table 1

Overview and the inclusion status of the four substudies

Substudy 1: a case–control study: haemolytic activity in ALS plasma
Course of study
  • Interviews.

  • Blood samples.

  • Separation of red blood cells and plasma.

  • Red blood cells incubated with blood type matched plasma with or without inactivated complement system.

  • The degree of haemolysis is measured and compared.

Subjects: aim/included so farALS: 25/25 NC: 25/25 NHC: 25/25
Substudy 2: a case–control study: collection of material for biobank and profiling of the complement system
Course of study
  • Interviews.

  • Blood samples and cerebrospinal fluid by lumbar puncture.

  • Biological material is prepared and freezed on site (−20°C).

  • Transportation of samples to central biobank for storage (−80°C).

  • Profiling of the complement system comparing the three groups.

Subjects: aim/Included so farALS: 100/98 NC: 100/61 NHC: 100/96
Substudy 3: a cohort study: collection of material for biobank and a study of the complement system over time
Course of study
  • The same course as in Substudy 2 repeated every 6 months

Subjects: aim/Included so farALS: 20/0 NC: — NHC: —
Substudy 4: pilot study: searching for complement activity in the neuromuscular junctions of patients with ALS
Course of study
  • Interviews.

  • Tru-cut biopsy from dominant lateral vastus muscle.

  • Transportation of muscle biopsy to Department of Neuropathology, Hospitalise.

  • Analysis of complement activity in muscle fibres and neuromuscular junctions.

Subjects: aim/Included so farALS: 10/0 NC: — NHC: —
  • ALS, amyotrophic lateral sclerosis; C, celsius; NC, neurological controls; NHC, neurologically healthy controls.