A Randomized Controlled Trial on Prophylactic Platelet Transfusion Prior to Central Venous Catheter Placement in Patients with Thrombocytopenia

Completed

Conditions: Low platelet Count
Platelet deficiency
10035534
10069888
10025309

Registration Number: NL-OMON50641

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 392

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study will be a procedure-related relevant<br /><br>bleeding, occurring within 24 hours after the procedure. A WHO grade 2-4 up to<br /><br>24 hours of randomization is defined as relevant bleeding. Based on<br /><br>observational studies we expect mainly grade 2 bleeding and no grade 3-4<br /><br>bleeding. It should be noted that clinical relevance of a grade 2 bleeding is<br /><br>still relatively low. An assessment of bleeding will be standardized and<br /><br>performed by an independent research physician blinded to the transfusion<br /><br>strategy 1 and 24 hours after the procedure and when clinically indicated. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- WHO grade 1 bleeding within 24 hours of CVC placement<br /><br>- allergic transfusion reaction within 24 hours<br /><br>- onset of acute lung injury within 48 hours.<br /><br>- length of hospital stay<br /><br>- number of RBCs and PC transfusions within 24 hours<br /><br>- costs<br /><br>Hemoglobin and platelet count will be measured at 1 and 24 hours after the<br /><br>procedure and when clinically indicated. </p><br>