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POC whole blood thrombin generation


- candidate number15522
- NTR NumberNTR4237
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2013
- Secondary IDsMETC-13-4-084 
- Public TitlePOC whole blood thrombin generation
- Scientific TitleClinical validation of the point of care whole blood thrombin generation assay.
- ACRONYM
- hypothesisWhole blood thrombin generation measurement is comparable to plasma thrombin generation in clinical setting.
- Healt Condition(s) or Problem(s) studiedCardiac surgery, Coagulopathy, Thrombin generation
- Inclusion criteriaAll consecutive patients after cardiac surgery during a period of 18 weeks.
- Exclusion criteriaage under 18 yrs. known coagulation disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 14-okt-2013
- planned closingdate31-jan-2014
- Target number of participants100
- Interventionsobservational study investigating coagulation capacity by the means of whole blood thrombin generation.
- Primary outcomeWhole blood thrombin generation results compared to automated plasma thrombin generation results
- Secondary outcome1. lab results (ROTEM, whole blood TG, classic coagulation tests)
2. clinical association with bleeding (amount of blood loss, fluid infusion and use of blood products)
- Timepointsmeasurement before and after surgery upon arrival on the ICU
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.D. LancÚ
- CONTACT for SCIENTIFIC QUERIESDr. M.D. LancÚ
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Synapse b.v.
- PublicationsN/A
- Brief summaryPost cardiac surgery patients may suffer from bleeding. For optimal tailoring hemostatic therapy thromboelastometry (ROTEM) is frequently used. Thrombin generation measurement could improve treatment. However this technique still is workintensive and time consuming. Whole blood thrombin generation might deliver the comparable results within a shorter period of time. It will be tested and compared to plasma thrombin generation, thromboelastometry and clinical parameters.
- Main changes (audit trail)
- RECORD8-okt-2013 - 19-nov-2013


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