NCT07616349 Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.
| NCT ID | NCT07616349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nicolas Brogly |
| Condition | Thrombocytopenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 85 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 85 participants in total. It began in 2026-05-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07616349 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07616349 currently recruiting?
Yes, NCT07616349 is actively recruiting participants. Contact the research team at nicolas.brogly@salud.madrid.org for enrollment information.
Where is the NCT07616349 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07616349 clinical trial?
NCT07616349 is sponsored by Nicolas Brogly. The trial plans to enroll 85 participants.