Thrombocytopenia Clinical Trials

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Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia: an Prospective Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Contact Information
Primary
Nicolas Brogly, MD, PhD
nicolas.brogly@salud.madrid.org
+34 663676820
Backup
Aránzazu Rodríguez Catalán, MD
arodriguezc293dd6@salud.madrid.org
+34 627476391
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 85
Treatments
Obstetric Patients with confirmed or suspicion of thrombocytopenia
The study will include all the consecutive consenting parturients admitted to our maternal unit in the inclusion period with the following inclusion and 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
Related Therapeutic Areas
Sponsors
Leads: Nicolas Brogly

This content was sourced from clinicaltrials.gov