Investigation of bleeding risk in pre-operative patients
Research type
Research Study
Full title
Investigation of changes in thromboelastography following fresh frozen plasma transfusion in pre-operative patient with mildly elevated prothrombin time.
IRAS ID
195973
Contact name
Jason Mainwaring
Contact email
Sponsor organisation
The Royal Bournemouth and Christchurch NHS foundation Trust
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Fresh frozen plasma (FFP) can be given pre-operatively, therapeutically if there is a known bleeding risk, or prophylactically if the international normalized ratio (INR) is raised without indication. However little evidence supports prophylactic use with INR’s less than 1.7, leading to a question of whether there is a genuine bleeding risk or if the risks of giving a blood product are justified. Research is needed to review the effect administration of FFP has on other clotting factors and evaluate the efficacy of FFP to prevent blood loss. Any patient fitting the inclusion/exclusion criteria for the study and is suitable for FFP transfusion as detailed in the Trust proforma will be considered for the trial. The requesting clinician will seek consent from the patient and attach a copy of the signed consent form to the request for FFP proforma.
An additional 2.7mls blood sample will be taken from 50 consenting patients before the FFP transfusion and 30 minutes after. This will involve an additional sample been taken when venepuncture is performed for the routine sampling. Both samples will be transported to the coagulation department. The research sample bag will additionally be labelled for the study.
On receipt of the samples in the Transfusion department, one sample will have the TEG (a diagnostic test to assess bleeding and clotting risk) performed and then both samples will be spun down and aliquots frozen for later analysis in batches.The full list of tests performed are listed in the protocol.
The clinicians responsible for the care of the patient will report any postoperative bleeding episodes, in addition the researchers will interrogate the patient records for bleeding episodes.
There is no specific follow up for this trial any follow up will be as clinically indicated.
Research Summary:
The study was terminated early after one participant had been recruited (at first due to the main researcher leaving the team, then the COVID-19 pandemic). With current and ongoing clinical pressures, the investigator team have been unable to restart recruitment; therefore the decision was taken by the Chief Investigator and Sponsor to close the study.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0102
Date of REC Opinion
8 Mar 2016
REC opinion
Favourable Opinion