Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 172 for:    "Heart Disease" | "Heparin"

Comparision Between Activated Partial Thromboplastin Time Versus Anti-Xa Activity in Heparin Monitoring (CATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426982
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Wuhan Asia Heart Hospital

Brief Summary:

Background:

Unfractionated heparin (UFH) is a sulfated polysaccharide extracted from porcine intestinal mucosa that enhances the inhibitory activity of the natural anticoagulant antithrombin towards most activated clotting factors (F), particularly FXa and FIIa (thrombin) . Despite the growing interest for low molecular weight derivatives (LMWH), UFH is still widely used for different indications including the treatment of acute thrombosis including venous thromboembolism, coronary syndromes (ACS), and other thrombotic diseases. UFH is administered by parenteral route either intravenous (IV) or sub-cutaneous (SC).Actually, there is evidence that the risk of recurrence of thrombosis is increased when heparin levels fells below the lower limit of the therapeutic range, while the hemorrhagic risk increases with heparin levels above the upper limit of the therapeutic range. Moreover, the anticoagulant response to UFH is highly variable for one individual to another. As the clinical efficacy of heparin is dependent on maintaining an anticoagulant effect above a minimum level, careful laboratory monitoring of UFH treatment is mandatory. For that purpose, two options are offered to the clinicians: i) to evaluate either the prolongation of a global clotting assay, the activated partial thromboplastin time (aPTT) and ii) to measure the heparin-enhanced inhibitory activity of AT toward purified activated factors such as FIIa and FXa using chromogenic substrate-based assays. UFH therapy is still widely monitored by the aPTT, a global clotting assay, that reflects the ability of heparin to enhance the inhibitory activity of AT against FIIa, FXa, and other activated factors. The therapeutic range of aPTT prolongation is highly dependent on the reagent and analyzer used. As the consequence, it must be defined by each laboratory in its own technical conditions (for each reagent batch) to correlate with heparin levels between 0.20 and 0.40 U/mL (protamine sulfate titration), corresponding to anti-FXa activity between 0.30 and 0.70 IU/mL. In that connection, the prolongation of aPTT corresponding to antiFXa activity between 0.30 - 0.70 IU/mL is highly variable depending of the reagents e.g.between 1.6 - 2.7 x control for weakly sensitive reagents and between 3.7 - 6.2 x control for highly sensitive reagents. The use of aPTT has advantages as it is easy-to-perform, quick, inexpensive but faces numerous challenges due to the significant influence of the technical conditions (reagent/instrument) on the test result, to lot-lot variation in reagent sensitivity, to the need of studies to evaluate the therapeutic range, to limited therapeutic range, and also to non-specific prolongation in the case of lupus anticoagulant, factors deficiency, inhibitors or shortening in the case of high factor levels, particularly FVIII.In contrast, the use of chromogenic anti-Xa assays has many advantages particularly a published therapeutic range for UFH i.e. between 0.30 and 0.70 IU/mL, a specificity to its interaction with AT (no Heparin Cofactor II interference by using bovine FIIa or short incubation time) and faces few challenges such as limited availability in some area and a cost that is slightly higher than that of aPTT. In addition, anti-Xa assays allow accurate measurement of all heparin(s) derivatives and particularly LMWHs and fondaparinux.

Since the first reports in the mid-eighties, some small sized studies have compared the two monitoring strategies mainly retrospectively designed (7-11). Even though, one single prospective randomized management study evaluated the comparison between the two monitoring strategies with clinical end-points i.e. recurrence of thrombosis and bleeding complication in a cohort of 131 patients with VTE . All concluded to a trend toward higher, or at least similar, safety/efficacy/efficiency when patients were monitored using antiXa activity vs. aPTT. Even though differences were not significant due to the lack of power of these studies.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Venous Thromboembolism Stroke Bleeding Drug: Unfractionated heparin Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

After randomization, the patients must be monitored using either anti-Xa activity or aPTT.

Only that specific test should be prescribed by the ward, and only that the corresponding test result be given by the laboratory.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Study Aimed at Comparing Activated Partial Thromboplastin Time and Anti-Xa Activity and in Patients Requiring Unfractionated Heparin Infusion
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Anti-Xa group
- Heparin was monitored by Anti-Xa activity, and clinicians adjusted dose of heparin to maintain it within the therapeutic range between 0.30 and 0.70 IU/mL
Drug: Unfractionated heparin
Infusion dose of unfractionated heparin was adjusted by anti-Xa

Experimental: APTT group
- Heparin was monitored by APTT, and clinicians adjusted dose of heparin to maintain it within the therapeutic range between 1.5 and 2.5 time the basiline.
Drug: Unfractionated heparin
Infusion dose of unfractionated heparin was adjusted by APTT




Primary Outcome Measures :
  1. Bleeding [ Time Frame: 30 days ]
    Any bleeding events including major bleeding and minor bleeding

  2. Ischemic vascular events [ Time Frame: 30 days ]
    Repeat MI, recurrence of thrombosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute venous thromboembolism,
  • acute coronary syndrome
  • receiving UFH therapy.

Exclusion Criteria:

  • non-willing to participate in the study,
  • thrombolytic therapy,
  • previous treatment with heparin (UFH) of more than one day before randomization,
  • history of heparin-induced thrombocytopenia.
  • other conditions considering by study clinians that are not suitable for the trail.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426982


Locations
Layout table for location information
China, Hubei
Wuhan Asia Heart Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact: zhang li tao, MD.P    +86 02765796739    zhangleetau@163.com   
Principal Investigator: zhang li tao, MD.P         
Sponsors and Collaborators
Wuhan Asia Heart Hospital

Layout table for additonal information
Responsible Party: Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT03426982     History of Changes
Other Study ID Numbers: 2018-P-002
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Myocardial Infarction
Thromboembolism
Venous Thromboembolism
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Dalteparin
Thromboplastin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants