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.
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the volume of blood loss during PDT
the intensity of intra-tracheal bleeding
time until no blood is visible in tracheal aspirates
Secondary outcome
The amount of bloodproducts used during and after tracheotomy
Background summary
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
Study objective
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
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.
Study burden and risks
The trial can only be done in ICU-patients. Due to the nature of their illness
and the frequent use of sedatives many patients are incapacitated.
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.
Meibergdreef
1105 AZ Amsterdam
Nederland
Meibergdreef
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
sub-clinical lengthening of coagulation tests and or low platelets
use of Ascal
planned PDT
age > 18 years
Informed consent
Exclusion criteria
contraindication for PDT (i.e., surgical tracheotomy is preferred)
contra-indications for transfusion of blood products
contra-indication for correction of coagulation disorders
PTT > 20 seconds
use of clopidogrel
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12894.018.06 |
| Other | pending |