Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNicolas Brogly
About this trial
This prospective observational, non-interventional, single-center study aims to evaluate whether the viscoelastic parameter PLTEM, derived from ROTEM® sigma testing (EXTEM-A5 minus FIBTEM-A5), can accurately estimate platelet count in obstetric patients with thrombocytopenia and/or severe postpartum hemorrhage.
The study will include pregnant women older than 18 years managed during labor and delivery at the Hospital General Universitario Gregorio Marañón, Madrid (Spain).
The primary objective is to validate the clinical usefulness of PLTEM as a rapid point-of-care tool to support clinical decision-making regarding neuraxial anesthesia and transfusion management in obstetric emergencies.
Eligibility criteria
Qualifiers
Parturients with a suspicion or confirmed thrombocytopenia before delivery (platelet count < 120x10^9/L),
Parturients with severe postpartum haemorrhage (blood loss >1500 mL) with a suspicion of thrombocytopenia.
Disqualifiers
parturient age under 18 years;
refusal to participate
Trial design
Treatments tested in this trial
- No Intervention: Observational Cohort
Treatment groups
85 Participants
are divided into 1 treatment groupSponsors and collaborators
Nicolas Brogly
Lead sponsor
Hospital General Universitario Gregorio Marañon
Sponsor institution
Source ClinicalTrials.gov