Circadian Variation of Anti-Factor Xa in Hospitalized Trauma Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inpatient admission for acute traumatic injury ≥72 hours

Prescribed LMWH subcutaneous for VTE chemoprophylaxis

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Hospitalized Trauma Patients Receiving LMWH Chemoprophylaxis

Trial outcomes

Primary outcomes

1

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)
2

Change in Antithrombin III (AT3) activity

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Sigma Theta Tau International Grant; Jerold B. Katz Endowment Fund

Collaborator