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The intensive care study of coagulopathy part 2

A prospective cross-sectional observational study of haemostatic testing in patients admitted to adult critical care with prolongation of prothrombin time without clinical bleeding

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50516147
Enrollment
200
Registered
2012-10-10
Start date
2013-01-02
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulopathy in intensive care Haematological Disorders Coagulation defect, unspecified

Interventions

Blood will be taken on enrolment, before and after Fresh Frozen Plasma transfusion or at the end of the study if no transfusion is given. The majority of patients will have central venous access or pe

Sponsors

NHS Blood and Transplant (NHSBT) (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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). 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.

Secondary

MeasureTime frame
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. 2. The number and severity of clinically significant bleeds will be recorded using a Bleeding Assessment Form

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026