QStat in Trauma and Obstetric Hemorrhage

NCT04385953 | Completed

• 1 other identifier: HEMCS-030
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients and obstetric patients with postpartum hemorrhage.

Conditions

Blood Loss Massive; Trauma; Post Partum Hemorrhage

Keywords

Viscoelastic testing; Coagulation; Quantra; Hemostasis

Outcome Measures

Primary Outcomes (2)

• Comparison of the Quantra results to corresponding ROTEM Delta results

  Coagulation function assessed by Quantra and ROTEM delta

  Upon arrival to emergency department

• Comparison of the Quantra results to corresponding ROTEM Delta results

  Coagulation function assessed by Quantra and ROTEM delta

  At the time of hemorrhage for obstetric patients

Study Arms (2)

Trauma patients

Subject experiencing major trauma

Diagnostic Test: Quantra System

Obstetric patients

Obstetric patient with postpartum hemorrhage

Diagnostic Test: Quantra System

Interventions

Quantra System DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care

Also known as: Quantra QStat Cartridge

Obstetric patients; Trauma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be adult (\>18 years) trauma patients or obstetric patients with postpartum hemorrhage where visicoelastic testing is performed as standard of care to assess coagulopathy.

You may qualify if:

• Subject is ≥ 18 years of age
• Subject is a trauma patient experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.and is a candidate for a ROTEM test to be performed to access coagulopathy.
• Subject is an obstetric patient experiencing post-partum hemorrhage based on one of the following conditions: estimated blood loss during delivery \>1000 mL; placental abruption with hemorrhage of any quantity; clinically suspected DIC; pregnancy resulted in fetal demise with hemorrhage of any quantity; or is under consideration for administration of tranexamic acid for treatment of hemorrhage.

You may not qualify if:

• Subject is younger than 18 years of age
• Subject presents for a procedure intended to abort a pregnancy for reasons other than medical necessity
• Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit
• Subject is currently enrolled in a distinct study that might confound the results of the proposed study
• Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 941109, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Postpartum Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: December 10, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)