No registrations found.
ID
Source
Brief title
Health condition
Central venous catheter, CVC, centraal veneuze lijn, coagulopathy, coagulopathie, platelet count, thrombocytopenia, trombocytopenie
Sponsors and support
Intervention
Outcome measures
Primary outcome
A procedure-related relevant bleeding, occurring within 24 hours after the procedure. A WHO grade 2-4 (appendix I) up to 24 hours of randomization is defined as relevant bleeding. Secondary study parameters/endpoints (if applicable)
Secondary outcome
- WHO grade 1 bleeding within 24 hours of CVC placement (appendix I)
- Adjusted WHO bleeding score, HEME-bleeding score (appendices II and III)
- 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 prior to the procedure and one hour and at 24 hours after the procedure and when clinically indicated. This is according to standard care.
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 109/L prior CVC placement. There is, however, no evidence to support correction of thrombocytopenia. On the other hand it has been proven that transfusion of platelets concentrates (PC) can be complicated by serious side effects. Furthermore, transfusion of PC is expensive. Retrospective studies suggest it is safe to place CVC independent of the platelet count down to 10 x 109/L. Our objective is to determine whether not correcting thrombocytopenia prior to CVC placement is non-inferior compared to correcting thrombocytopenia, in a controlled setting.
Study objective
Not correcting thrombocytopenia prior to CVC placement in patients is non-inferior compared to correcting thrombocytopenia.
Study design
Directly after CVC insertion, 1 hour, 24 hours.
Intervention
Eligible patients will be randomly assigned to either receiving one unit of platelet concentrate, or no platelet concentrate. There will be no placebo treatment. Rescue platelet concentrate will be available for administration at clinicians’ discretion. Blinding for the outcome will be performed for the researcher, not for the physicians and patients.
Meibergdreef 9
A.P.J. Vlaar
Amsterdam 1105 AZ
The Netherlands
-
a.p.vlaar@amc.uva.nl
Meibergdreef 9
A.P.J. Vlaar
Amsterdam 1105 AZ
The Netherlands
-
a.p.vlaar@amc.uva.nl
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 as Thrombotic thrombocytopenic purpura, or Congenital IgA deficiency
3. Randomization in the previous 24 hours
4. Patients with a history of congenital or acquired coagulation factor deficiency or bleeding diathesis
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL5534 |
| NTR-old | NTR5653 |
| Other | 843002625, ZonMW : 2015_278, METC AMC |