Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000055202
Ethics application status
Approved
Date submitted
30/06/2008
Date registered
23/01/2009
Date last updated
23/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the correlations of anticoagulant effects between Thromboelastography [TEG] and anti-Xa activity in patients on therapeutic dose of low-molecular-weight heparin (LMWH)?
Scientific title
Assessing the correlations of anticoagulant effects between Thromboelastography [TEG] and anti-Xa activity in patients on therapeutic dose of low-molecular-weight heparin (LMWH)?
Secondary ID [1] 774 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 3340 0
Condition category
Condition code
Blood 3493 3493 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.)
Intervention code [1] 3072 0
Not applicable
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4398 0
Correlations between thromboelastogram and anti-Xa activity
Timepoint [1] 4398 0
4 hours post dose on day 3
Secondary outcome [1] 7428 0
Effects of dose levels on renal function and obesity measured by renal failure and body mass.
Timepoint [1] 7428 0
On admission

Eligibility
Key inclusion criteria
All patients on high dose enoxaparin for acute coronary syndrome in the coronary care unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3536 0
Self funded/Unfunded
Name [1] 3536 0
Hayden White
Country [1] 3536 0
Australia
Primary sponsor type
Individual
Name
Hayden White
Address
Logan Hospital
Cnr Armstrong & Loganlea Roads MEADOWBROOK Qld 4131
Country
Australia
Secondary sponsor category [1] 3174 0
None
Name [1] 3174 0
Address [1] 3174 0
Country [1] 3174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5574 0
Princess Alexandra Hospital ethics committee
Ethics committee address [1] 5574 0
Princess Alexandra Hospital
199 Ipswich Road WOOLLOONGABBA QLD 4102
Ethics committee country [1] 5574 0
Australia
Date submitted for ethics approval [1] 5574 0
Approval date [1] 5574 0
20/06/2008
Ethics approval number [1] 5574 0
2008/115

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28713 0
Address 28713 0
Country 28713 0
Phone 28713 0
Fax 28713 0
Email 28713 0
Contact person for public queries
Name 11870 0
Hayden White
Address 11870 0
Logan Hospital
Cnr Armstrong & Loganlea Roads MEADOWBROOK Qld 4131
Country 11870 0
Australia
Phone 11870 0
+61732998775
Fax 11870 0
Email 11870 0
[email protected]
Contact person for scientific queries
Name 2798 0
Hayden White
Address 2798 0
Logan Hospital
Cnr Armstrong & Loganlea Roads MEADOWBROOK Qld 4131
Country 2798 0
Australia
Phone 2798 0
+61732998775
Fax 2798 0
Email 2798 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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