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
This trial does not accept healthy volunteersQualifiers
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 population
Cohort of consecutive consenting patients with suspicion and/or confirmed thrombocytopenia admitted in the labor ward, the obstetric operating room or the obstetric post anaesthetic care unit for delivery in a tertiary university hospital in Madrid-Spain for a period of 1 year.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention: observational study
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Obstetric Patients with confirmed or suspicion of thrombocytopenia1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the correlation between PLTEM value and platelet count on hemogram
A blood sample will be extracted in patients at risk or with confirmed thrombcytopenia. A simultaneous platelet count (standard biological test) and ROTEM sigma viscoelastic test will be performed. The correlation between PLTEM5 (EXTEM A5 - FIBTEM A5), PLTEM10 (EXTEM A10 - FIBTEM A10) and platelet count will be determined.
Time frame
At admission to the labour ward in case of thrombocytopenia inferior to 120,000 /mm^3 platelets in the third trimester of pregnancy, or at diagnosis of a severe Post-Partum Hemorrhage > 1,500 mL, until 24 hours after delivery or cesarean delivery.Secondary outcomes
1
Relationship between ROTEM® parameters, thrombocytopenia, and fibrinogen levels
To assess the correlation between ROTEM® sigma-derived parameters (FIBTEM, EXTEM, and INTEM) and standard coagulation assays, including: Clauss fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT), in obstetric patients with thrombocytopenia and/or postpartum hemorrhage ≥1,500 mL, with the aim of characterizing the coagulopathy profile in these scenarios, with particular attention to hypofibrinogenemia and platelet function.
Time frame
From admission to the labour ward or from diagnosis of severe postpartum hemorrhage (>1,500 mL), through 24 hours postpartum.2
PLTEM threshold for safe neuraxial anesthesia in thrombocytopenic obstetric patients
To assess whether a specific PLTEM threshold can be determined with ROTEM® sigma to identify obstetric patients above the established safety platelet count threshold for neuroaxial anesthesia (≥ 70 × 10⁹/L) in a clinically useful timeframe compared to conventional laboratory test.
Time frame
At admission to the labour ward.Sponsors and contacts
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Nicolas Brogly
Lead sponsor
Hospital General Universitario Gregorio Marañon
Sponsor institution
Source ClinicalTrials.gov