Low platelet Count Platelet deficiency
Conditions
Interventions
No transfusion (experimental arm) or transfusion (control arm) of 1 unit
platelets concentrate (PC) prior placement of CVC
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Netherlands
Outcome results
None listed