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Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.

NCT07616349 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2026-06-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

No Intervention: Observational Cohort

No intervention: observational study

Sponsors & Collaborators

  • Nicolas Brogly

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616349 on ClinicalTrials.gov