Circadian Variation of Anti-Factor Xa in Hospitalized Trauma Patients

NCT07856641 | Recruiting

• 1 other identifier: HSC-SN-25-0184
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a circadian rhythm exists in anti-FXa levels and AT3 activity in hospitalized trauma patients receiving low-molecular-weight heparin (LMWH) chemoprophylaxis

Conditions

Circadian Variation in Anti-Factor Xa (Anti-FXa) Activity

Keywords

Blood thinner; circadian rhythm; Venous thromboembolism (VTE)

Outcome Measures

Primary Outcomes (2)

• Change in anti-factor Xa (anti-FXa) levels

  4 hours after the 3rd LMWH dose (T0), then every 6 hours (T6, T12, T18)

• Change in Antithrombin III (AT3) activity

  4 hours after the 3rd LMWH dose (T0), then every 6 hours (T6, T12, T18)

Study Arms (1)

Hospitalized Trauma Patients Receiving LMWH Chemoprophylaxis

Hospitalized trauma patients receiving low-molecular-weight heparin (LMWH) chemoprophylaxis as part of routine clinical care. Participants will have anti-FXa levels and antithrombin III (AT3) activity measured at predefined time points to evaluate potential circadian variation in these measures.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted at HCA Houston Northwest Medical Center and will include adult trauma patients admitted to the Trauma ICU and Trauma Surgical Floor

You may qualify if:

• Inpatient admission for acute traumatic injury ≥72 hours
• Prescribed LMWH subcutaneous for VTE chemoprophylaxis

You may not qualify if:

• Pregnancy
• Brain hemorrhage or non-survivable injury
• Chronic Kidney disease ≥ 3b estimated Glomerular Filtration Rate (eGFR) less than 30 interferes with coagulation
• Chronic liver failure
• -Acute stimulant use of cocaine and methamphetamine
• Active VTE or ongoing anticoagulation at admission
• History of coagulopathy or inherited bleeding disorders
• Chronic alcohol as defined as a documented diagnosis of alcohol use disorder or alcohol consumption exceeding established risk thresholds (men \>14 drinks/week; women \>7 drinks/week) within the prior 3-6 months
• Unmanaged psychiatric conditions as defined as diagnosed psychiatric disorder with evidence of inadequate or no active treatment or documented poor symptom control
• Neurologic injury involving hypothalamic or circadian regulatory centers

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Sigma Theta Tau International Grant; Jerold B. Katz Endowment Fund: collaborator

Study Sites (1)

HCA Houston Northwest Medical Center

Houston, Texas, 77090, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Behavior; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Evaline W Kihara, MSN, APRN, AGACNP-BC, CCRN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Shiree Berry, MD

  HCA Houston NW Medical center- Trauma Medical Director

  STUDY DIRECTOR

Central Study Contacts

Evaline W Kihara, MSN, APRN, AGACNP-BC, CCRN

CONTACT

(713) 500-6362; Evaline.W.Kihara@uth.tmc.edu

Nikhil Padhye, PhD

CONTACT

(713) 500-2035; Nikhil.S.Padhye@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acute Care Nurse Practitioner

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): August 26, 2027
• Study Completion (Estimated): March 26, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)