Our objective is to determine in a controlled study whether not correcting thrombocytopenia prior to CVC placement is non-inferior compared to correcting. In the Netherlands annually 17.700 units PC are possibly unnecessary transfused, for the…
ID
Source
Brief title
Condition
- Platelet disorders
- Procedural related injuries and complications NEC
- Haematological and lymphoid tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study will be a procedure-related relevant
bleeding, occurring within 24 hours after the procedure. A WHO grade 2-4 up to
24 hours of randomization is defined as relevant bleeding. Based on
observational studies we expect mainly grade 2 bleeding and no grade 3-4
bleeding. It should be noted that clinical relevance of a grade 2 bleeding is
still relatively low. An assessment of bleeding will be standardized and
performed by an independent research physician blinded to the transfusion
strategy 1 and 24 hours after the procedure and when clinically indicated.
Secondary outcome
- WHO grade 1 bleeding within 24 hours of CVC placement
- allergic transfusion reaction within 24 hours
- onset of acute lung injury within 48 hours.
- length of hospital stay
- number of RBCs and PC transfusions within 24 hours
- costs
Hemoglobin and platelet count will be measured at 1 and 24 hours after the
procedure and when clinically indicated.
Background summary
Critically ill and hematologic patients undergoing therapy need a central
venous catheter (CVC). These patients often suffer from thrombocytopenia at the
moment of CVC placement. The current national and international guidelines
support correction of thrombocytopenia up to a platelet count of 50 x 10^9/L
prior to CVC placement. There is, however, no evidence to support correction of
thrombocytopenia. On the other hand it has been proven that transfusion of
platelet concentrates (PC) can be complicated by serious side effects.
Furthermore, transfusion of PC is expensive (à ¤ 520,-). Retrospective studies
suggest it is safe to place CVC independent of the platelet count down to 10 x
10^9/L.
Study objective
Our objective is to determine in a controlled study whether not correcting
thrombocytopenia prior to CVC placement is non-inferior compared to correcting.
In the Netherlands annually 17.700 units PC are possibly unnecessary
transfused, for the current study population the abandoning of PC transfusion
prior CVC placement would result in a 9.2 million Euro cost reduction.
HYPOTHESIS: Not correcting thrombocytopenia prior to CVC placement in patients
is safe
Study design
Multicenter randomized controlled trial
Intervention
No transfusion (experimental arm) or transfusion (control arm) of 1 unit
platelets concentrate (PC) prior placement of CVC
Study burden and risks
CVC placement is suggested to be frequently complicated with bleeding as
hematologic and critically ill patients often suffer from severe
thrombocytopenia (5-75%) at the moment of CVC placement. However, this was
based on placement of CVC using landmark techniques. From this perspective
current national and international guidelines still support correction of
thrombocytopenia up to a platelet count of 50x10^9/L prior to CVC placement.
Exposure of patients to blood products bears a risk for transfusion related
morbidity and mortality.[8,9] Many years transfusion has been regarded as a
safe intervention; however during the past decades it has become clear that
transfusion has a substantial risk for morbidity and mortality. Examples are
transfusion-related acute lung injury, transfusion associated cardiac overload,
allergic reactions, allo-immunization and the risk of transfusion related
infections. Next to the burden of transfusion exposure, blood products are
expensive and scarce.
In recent years CVC placement techniques have changed. It is now standard
practice to perform ultrasound-guided placement which results in a lower number
of puncture attempts and lower complication rate. As mentioned above prevention
of bleeding complications is the reason to correct thrombocytopenia prior to
CVC placement. Interestingly, recent retrospective studies suggest that the
experience of the physician and the technique used (ultrasound vs. landmark)
rather than the platelet count predicts bleeding complications. However,
limitations of these studies were the small number of patients included and the
absence of a control group. We believe that the improved standards of CVC
placement, e.g. the use of ultrasound, make correction of thrombocytopenia
prior to CVC placement obsolete.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Age>18 years
2. Need for CVC placement at the clinician*s discretion
3. Platelet count between 10*50x109/L
4. INR*3.0
5. Informed consent
Exclusion criteria
1. Use of therapeutic anticoagulant therapy, except single antiplatelet therapy
2. Contra-indication for PC transfusion, such Thrombotic thrombocytopenic
purpura, or Congenital IgA deficiency.
3. Randomization in the current trial, in the previous 24 hours.
4. Patients with a history of congenital or acquired coagulation factor
deficiency or bleeding diathesis.
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 | NL54569.018.15 |