The intensive care study of coagulopathy part 2
Not Applicable
Completed
- Conditions
- Coagulopathy in intensive careHaematological DisordersCoagulation defect, unspecified
- Registration Number
- ISRCTN50516147
- Lead Sponsor
- HS Blood and Transplant (NHSBT) (UK)
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29637582
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1. Admission to a general intensive care unit
2. Prolongation of the PT time by more than 3 seconds beyond the upper limit of the normal range for local hospital within 48 hours of admission
Exclusion Criteria
1. No evidence of active clinical bleeding at the time of enrolment (for example active blood loss through post-operative drains, or clinically significant bleeding, defined as an estimated total cumulative blood loss > 300ml)
2. Warfarin therapy or other treatment dose anticoagulant therapy at the time of enrolment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Haemostasis will be measured using traditional coagulation tests [ prothrombin time (PT), activated partial thromboplastin time (APTT), platelets, fibrinogen) and the new whole blood techniques of assessing clot formation and breakdown TG, Thrombelastography (TEG) and thromboelastometry (ROTEM).<br><br> Clotting factor levels, vWF levels, antithrombin, proteins c and s levels will be measured, in cases where there is a disproportionate difference between PT and the newer techniques of measuring coagulopathy.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. The effect of transfusing FFP will be measured using traditional coagulation tests (PT, APTT, platelets, fibrinogen) and the new whole blood techniques of assessing clot formation and breakdown TG, TEG and ROTEM.<br> 2. The number and severity of clinically significant bleeds will be recorded using a Bleeding Assessment Form<br>