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van CCT (UK)

van CCT (UK)

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

- candidate number23659
- NTR NumberNTR5653
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jan-2016
- Secondary IDs2015_278, METC AMC 843002625, ZonMW
- Public TitleOnderzoek naar de noodzaak van correctie van bloedplaatjestekort voor het plaatsen van een centraal veneuze lijn
- Scientific TitleProphylactic Platelet Transfusion Prior to Central Venous Catheter Placement in Patients with Thrombocytopenia
- hypothesisNot correcting thrombocytopenia prior to CVC placement in patients is non-inferior compared to correcting thrombocytopenia.
- Healt Condition(s) or Problem(s) studiedThrombocytopenia
- Inclusion criteria1. Age>18 years
2. Need for CVC placement at the clinician’s discretion
3. Platelet count between 10–50x109/L
4. INR<1.5
5. Informed consent
- Exclusion criteria1. 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. Previous randomization in the current trial
4. Patients with a history of congenital or acquired coagulation factor deficiency or bleeding diathesis
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-okt-2019
- Target number of participants392
- InterventionsEligible 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.
- Primary outcomeA 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.
- TimepointsDirectly after CVC insertion, 1 hour, 24 hours.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNone
- Brief summaryCritically 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.
- Main changes (audit trail)15-dec-2017 -IK:

Exclusion criteria:
"3. Previous randomization in the current trial"

replaced by

"3. Randomization in the previous 24 hours"
- RECORD27-jan-2016 - 15-dec-2017

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