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Assessing the correlations of anticoagulant effects between Thromboelastography [TEG] and anti-Xa activity in patients on therapeutic dose of low-molecular-weight heparin (LMWH)?

Assessing the correlations of anticoagulant effects between Thromboelastography [TEG] and anti-Xa activity in patients on therapeutic dose of low-molecular-weight heparin (LMWH)?

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000055202
Enrollment
60
Registered
2009-01-23
Start date
2008-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim of the study In this study we intend to find whether TEG parameters in patients on therapeutic dosage of LMWH correlated with anti Xa levels and other coagulation parameters. Background Low molecular weight heparin is commonly used in the management of acute coronary syndromes (ACS). Currently there is no easy method to monitor the degree of anticoagulation from LMWH. Since LMWH inhibits coagulation factor Xa, measuring the anti-Xa activity is a good way to assess the anticoagulant effects of LMWH, but the results may not be readily available. Other coagulation parameters like the activated partial thromboplastin time [aPTT] may not correlate well with the degree of anticoagulation. The thromboelastography is a near patient test which can be used to define the viscoelastic properties of blood. It also provides information about platelet activation, fibrin formation and clot retraction. As a result TEG has the potential to predict the degree of anticoagulation from LMWH. From the available data, TEG parameters have been compared with the anti-Xa levels when LMWH was given in low doses as prophylaxis for deep vein thrombosis. There is no literature to highlight the usefulness of TEG in patients on therapeutic doses of LMWH for acute coronary syndromes. The purpose of the study is to investigate the correlation between the TEG parameters, anti Xa levels and other coagulation tests in patients on therapeutic dose LMWH. Furthermore, we intend to investigate the effects of renal function and body mass on the current dosing guidelines for LMWH.

Interventions

1."The thromboelastography is used to define the viscoelastic properties of blood to potentially predict the degree of anticoagulation from LMWH. All patients admitted to the critical care unit (CCU) with acute coronary syndromes (ACS) are started on LMWH. A blood sample will be taken once 4 hours after the therapeutic dose of enoxaparin is given on day 3. A TEG will be performed on these samples along with the anti-Xa levels and other coagulation parameters. Thromboelastograph Protocol for Sodi

1."The thromboelastography is used to define the viscoelastic properties of blood to potentially predict the degree of anticoagulation from LMWH. All patients admitted to the critical care unit (CCU) with acute coronary syndromes (ACS) are started on LMWH. A blood sample will be taken once 4 hours after the therapeutic dose of enoxaparin is given on day 3. A TEG will be performed on these samples along with the anti-Xa levels and other coagulation parameters. Thromboelastograph Protocol for Sodium Citrated samples Specimen 1. Blood is drawn via venipuncture from the patient into Greiner Vacuette(Registered) #9NC (sodium citrate) Coagulation tubes. The samples must be filled to the mark and inverted 3 times to adequately mix the sample. 2. The exact collection time MUST be written onto the specimen. 3. The specimen will then be sent immediately to pathology for processing. 4. Samples are "rested" (undisturbed) for a minimum of 15 mins prior to analysis. Protocol 1. Routine daily maintenance and QC will be undertaken as per lab protocol. 2. Disposable cups and pins are placed into the TEG cup and allowed to warm to 370C. 3. Patient data is entered into the computer as required. 4. 20µl of 0.2M Calcium Chloride (CaCl2) is added to the TEG test cup. 5. The citrated sample is well mixed by gentle inversion, and 1 ml transferred to a vial of Kaolin activator. 6. This sample is mixed 5 times by inversion and 340µl pipetted into the TEG cup. 7. The carrier is raised until flush with the instrument, the lever placed in the "test" position and the test started in the usual manner. 8. The second channel can by activated by following steps from 2 above for additional testing if required." 2. 3.Pts do not receive LMWH prior to admission 4.Normal patients receive enoxaparin 1mg/kg twice daily subcutaneously 5.Patients with eGFR < 30 ml/min receive 1mg/kg daily 6.Obese patients (BMI > 35kg/m2) receive 1 mb/kg based on lean body mass (note. the length of time patients are on enoxaparin once TEG has been performed is irrelevant to the study.)

Sponsors

Hayden White
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients on high dose enoxaparin for acute coronary syndrome in the coronary care unit

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026