Correction of Sub-clinical Prolongation of COAGulation Tests and/or Low Platelets before TRACHeotomy. (Randomized controlled trial).

Background of the study:

Percutaneous dilational tracheotomy (PDT) is increasingly performed in mechanically ventilated intensive care unit (ICU)–patients. One of the complications of PDT, however, is peri-procedural bleeding, although the risk is normally very low. A large majority of ICU–patients demonstrate abnormalities in the coagulation system, varying from sub-clinical prolongation of coagulation tests and/or low platelets, to more severe coagulation disorders, better known as disseminated intravascular coagulation (DIC). For prolongation of coagulation tests (PTT > 20 seconds) and low platelets (platelets < 50 x 10e9/L), usually plasma and platelet concentrates are transfused before tracheotomy is performed. There are no clear guidelines on prolongation of PTT > 14.7 seconds, platelets < 100 x 10e9/L and patients using Ascal. Transfusion of blood products bears the risk of transmission of infectious diseases. In addition, the use of plasma products increases the risk of transfusion-associated acute lung injury (TRALI). Furthermore, it is uncertain whether plasma and/or platelets transfusion truly influences the risk of bleeding in patients with sub-clinical prolongation of coagulation tests and low platelets during PDT

Objective of the study:

To determine if patients with sub-clinical lengthening of coagulation test, low platelets or use of Ascal have increased risk of clinical significant bleeding during and after tracheotomy.

Study design:

Randomized controlled trial

Study population:

ICU-patients, older than 18 years, with sub-clinical lengthening of coagulation tests (PTT 14.7 – 20 seconds, platelets < 100 x 10e9/L) or the use of Ascal who recieve a tracheotomy

Intervention:

In group 1 patients receive platelets and/or plasma before PDT until normal values are reached. In group 2 patients do not receive platelets and/or plasma.

Primary study parameters/outcome of the study:

the volume of blood loss during PDT
the intensity of intra-tracheal bleeding
time until no blood is visible in tracheal aspirates

Secundary study parameters/outcome of the study (if applicable):

The amount of bloodproducts used during and after tracheotomy

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

All interventions are part of the standard care surrounding patients that recieve tracheotomy. Therefore the extent of the burden should be regarded as small.
Bloodproducts will be available for immediate administration during PDT, if necessary to decrease the risk of bleeding.

Correction of sub-clinical prolongation of coagulation tests (i.e., PTT between 14.7 – 20 seconds and platelets < 100 x 109/L) and transfusion of platelets in patients with Ascal®, significantly decreases the incidence of clinical significant peri-procedural bleeding.

In group 1 patients receive platelets and/or plasma before PDT until normal values are reached. In group 2 patients do not receive platelets and/or plasma.