Circadian Variation of Anti-Factor Xa in Trauma Patients on LMWH
Official title: Circadian Variation of Anti-Factor Xa in Hospitalized Trauma Patients
Run by The University of Texas Health Science Center, Houston · NCT07856641 · Data updated 2026-11-12
This study tests whether anti-Factor Xa levels show a daily rhythm in hospitalized trauma patients receiving LMWH for VTE prevention.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | August 26, 2026 |
| Main results expected | August 26, 2027 |
| Study ends | March 26, 2028 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07856641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults hospitalized for acute traumatic injuries (≥72 hours) who are prescribed subcutaneous LMWH for VTE chemoprophylaxis.
✕Probably not a fit
Patients with active VTE, significant liver or kidney disease, certain brain injuries, or other exclusions may not experience a benefit from timing considerations.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates if anti-FXa activity and AT3 levels vary with the time of day in hospitalized trauma patients treated with low-molecular-weight heparin for VTE chemoprophylaxis. The study will monitor LMWH-related anticoagulation markers to identify any circadian patterns. The findings could help understand whether dosing or monitoring should consider time-of-day effects in this population. Inclusion targets adults with acute traumatic injury admitted for at least 72 hours who are receiving LMWH, while excluding patients with certain comorbidities or conditions that could confound coagulation or circadian regulation. No interventions are described.
Why it matters
Potential benefit: If a circadian pattern is found, it could inform timing considerations for LMWH prophylaxis to optimize effectiveness.
How similar studies have gone: Previous research in other settings has explored circadian variation in coagulation markers, but this specific association in trauma patients on LMWH is novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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HCA Houston Northwest Medical Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Evaline W Kihara, MSN, APRN, AGACNP-BC, CCRN — The University of Texas Health Science Center, Houston
- Study coordinator: Evaline W Kihara, MSN, APRN, AGACNP-BC, CCRN
- Email: Evaline.W.Kihara@uth.tmc.edu
- Phone: (713) 500-6362
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.