Cryoglobulin thermal stability

• Research type

  Research Study

• Full title

  Study to assess thermal stability of cryoglobulins

• IRAS ID

  302104

• Contact name

  Shirley D'Sa

• Contact email

  s.d'sa@nhs.net

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  145271, UCL Data protection

• Duration of Study in the UK

  1 years, 0 months, 5 days

• Research summary

  Cryoglobulinemia is a clinical disorder characterised by the presence of immunoglobulins that precipitate at cold temperatures (below 37˚C) in serum and redissolve on warming. It may be associated with clonal and polyclonal disorders including lymphoproliferative disorders, autoimmune conditions and viral infections. Symptoms may be multisystemic (including cutaneous skin and vasomotor manifestations, peripheral nerve, renal and pulmonary involvement) and therefore present to a number of specialties. It has an estimated prevalence of 1 in 100,000.
  Accurate detection of cryoglobulins requires patient blood samples to be taken into pre-warmed tubes from the clinic to the laboratory which must not be allowed to cool below 37˚C. This poses a challenge where the laboratory is a distance from the main hospital or site of phlebotomy as temperature control may be difficult to maintain. Heating flasks to above 37˚C may overcome this problem. This study aims to establish whether cryoglobulins can be detected and measured across different temperatures at and above 37˚C. This has the impact of allowing potentially less restrictive collection of samples and facilitate detection of cryoglobulins where laboratories are at considerable distances from patient blood sampling.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  22/NW/0135

• Date of REC Opinion

  26 Apr 2022

• REC opinion

  Favourable Opinion