Recruiting

LMWH

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07856641

Conditions

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07856641

Start date

Aug 26, 2026

Status verified date

Sep, 2026

Completion date

Mar 26, 2028

Anticipated

Primary completion date

Aug 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Change in anti-factor Xa (anti-FXa) levels [ Time Frame: 4 hours after the 3rd LMWH dose (T0), then every 6 hours (T6, T12, T18) ]
  • Change in Antithrombin III (AT3) activity [ Time Frame: 4 hours after the 3rd LMWH dose (T0), then every 6 hours (T6, T12, T18) ]

Central Contacts and Locations

Central contacts

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

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

Nikhil Padhye, PhD

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

Locations

HCA Houston Northwest Medical Center

Recruiting

Houston, Texas, United States, 77090

Contacts

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

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

Nikhil Padhye

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • Blood thinner
  • circadian rhythm
  • Venous thromboembolism (VTE)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.