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Onderzoek naar de noodzaak van correctie van bloedplaatjestekort voor het plaatsen van een centraal veneuze lijn

Prophylactic Platelet Transfusion Prior to Central Venous Catheter Placement in Patients with Thrombocytopenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27018
Enrollment
392
Registered
2016-01-27
Start date
2016-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central venous catheter, CVC, centraal veneuze lijn, coagulopathy, coagulopathie, platelet count, thrombocytopenia, trombocytopenie

Interventions

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 av

Sponsors

Acamedic Medical Center
Lead Sponsor

Eligibility

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 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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Contacts

Public ContactA.P.J. Vlaar

Department of Intensive Care Medicine Meibergdreef 9

a.p.vlaar@amc.uva.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)