## Protocol Section
### Identification Module
**NCT ID:** NCT06415760

**Brief Title:** Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients

**Official Title:** Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients

#### Organization Study ID Info
**ID:** HEMCS-047
#### Organization
**Class:** INDUSTRY
**Full Name:** HemoSonics LLC
### Status Module
#### Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** HemoSonics LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy

**Detailed Description:** During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy.

### Conditions Module

**Conditions:**

- Obstetric Hemostasis

- Coagulation

**Keywords:**

- Quantra

- Viscoelastic testing

- Coagulation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy.

**Intervention Names:**

- Diagnostic Test: Quantra System

**Label:** Obstetric Patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Obstetric Patients

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

**Name:** Quantra System

**Other Names:**

- QStat Cartridge

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Reference range intervals for CSL for pregnant women in third trimester

**Measure:** Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter

**Time Frame:** Baseline, determined from a single blood draw

**Description:** Reference range intervals for FCS for pregnant women in third trimester

**Measure:** Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter

**Time Frame:** Baseline, determined from a single blood draw

**Description:** Reference range intervals for PCS for pregnant women in third trimester

**Measure:** Reference range intervals for measurement of Platelet Contribution (PCS) parameter

**Time Frame:** Baseline, determined from a single blood draw

**Description:** Reference range intervals for CS for pregnant women in third trimester

**Measure:** Reference range intervals for measurement of Clot Stiffness (CS) parameter

**Time Frame:** Baseline, determined from a single blood draw

**Description:** Reference range intervals for CT for pregnant women in third trimester

**Measure:** Reference range intervals for measurement of Clot Time (CT) parameter

**Time Frame:** Baseline, determined from a single blood draw

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject is female, age 18 to 45 years old.
* Subject is pregnant with a single fetus and duration of pregnancy is \>28weeks
* Subject is willing to participate and has provided informed consent.

Exclusion Criteria:

* Subject has a history of a coagulation disorder (including excessive bleeding, thrombosis, VWD, or any factor deficiencies).
* Subject has taken medications known to alter coagulation during pregnancy including heparin, warfarin/Coumadin®, antiplatelet drugs including Plavix® or aspirin at a dose greater than 81 mg/day, Xarelto® or Eliquis®, or other anticoagulants.
* Subject has experienced one or more complications during pregnancy such as gestational diabetes, high blood pressure, pre-eclampsia or eclampsia, hypovolemia or pre-term labor.
* Subject had a blood transfusion during pregnancy.
* Subject has a history of smoking/vaping during pregnancy

**Gender Based:** True

**Gender Description:** Pregnant women

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Adult pregnant women 18 years of age or older in their third trimester of pregnancy with no prenatal risk factors and an uncomplicated pregnancy.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Raleigh

**Country:** United States

**Facility:** Unified Womens Clinical Research

**State:** North Carolina

**Zip:** 27612

**Location 2:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Unified Womens Clinical Research

**State:** North Carolina

**Zip:** 27103

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
