Estimating Platelet Counts with ROTEM PLTEM in Laboring Women with Low Platelets or Heavy Bleeding
Official title: Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia: an Prospective Observational Study
Run by Hospital General Universitario Gregorio Marañon · NCT07616349 · Data updated 2026-11-12
This study tests whether the PLTEM value from ROTEM sigma testing can quickly estimate platelet count in pregnant women with low platelets or severe postpartum hemorrhage to help decisions about anesthesia and transfusions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 85 (estimated) |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Locations | 1 site (Madrid) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07616349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18 or older managed during labor and delivery who have suspected or confirmed thrombocytopenia (platelets <120x10^9/L) or severe postpartum hemorrhage (>1500 mL).
✕Probably not a fit
Patients without thrombocytopenia or severe hemorrhage or those whose PLTEM does not correlate with platelet count may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, observational study conducted at Hospital General Universitario Gregorio Marañón in Madrid. It will measure PLTEM, calculated as EXTEM-A5 minus FIBTEM-A5, to see how well it reflects platelet count in obstetric patients with thrombocytopenia and/or severe postpartum hemorrhage. No interventions are performed; the study observes current clinical management and outcomes. The goal is to determine if PLTEM can serve as a rapid point-of-care tool to support neuraxial anesthesia decisions and transfusion strategies in obstetric emergencies.
Why it matters
Potential benefit: If PLTEM reliably estimates platelet count, clinicians could make quicker, safer decisions about anesthesia and blood product use during obstetric emergencies.
How similar studies have gone: ROTEM-based platelet assessments have shown promise in other settings, but validation in obstetric patients is limited and still evolving.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * 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. Exclusion criteria: * parturient age under 18 years; * refusal to participate
Where it's running
-
Hospital General Universitario Gregorio Marañón
Madrid, Spain Recruiting
Study contacts
- Study coordinator: Nicolas Brogly, MD, PhD
- Email: nicolas.brogly@salud.madrid.org
- Phone: +34 663676820
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.