LMWH-VTE Prophylaxis for Survivors of Acute Ischemic Stroke- Assessment of Standard Dosing Regimen

NCT03593291 | Unknown

• 1 other identifier: 0022-17-LOE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The anti-factor Xa (anti-Xa) assay is a functional assay that facilitates the measurement of antithrombin (AT)-catalyzed inhibition of factor Xa by unfractionated heparin (UFH) and direct inhibition of factor Xa by low-molecular-weight heparin (LMWH). As a result, Anti-factor Xa level reflect the in situ pharmacological activity of LMWH. 0.2 to 0.5 units/ml has been considered to be the desired level for prevention of VTE. Although this method was available since the 1970s, their cost was viewed to prohibit their broad use until recently. Previous studies determined the safety and effectiveness of fixed dose prophylactic regiments via clinical outcomes. This strategy has several shortcomings. The current study was there for devised to examine in vivo activity of LMWH in patients receiving a fixed dose prophylactic regimen, in order to assess the effectiveness of this method.

Conditions

Stroke

Keywords

Stroke, VTE prophylaxis, Anti Xa

Outcome Measures

Primary Outcomes (1)

• Anti-Xa level

  Flowing at least 7 consecutive days of treatment blood sample will be drown 3-4 hours post LMWH administration and sent for The anti-factor Xa (anti-Xa) assay.

  3-4 hours post LMWH administration

Interventions

Anti Xa DIAGNOSTIC_TEST

Levels of Anti Xa measure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for rehabilitation following acute ischemic stroke in 2018

You may qualify if:

• Acute Ischemic stroke per imaging study
• Clinical decision to administer VTE prophylaxis. (i.e.patients in whom a diagnosis of hemorrhagic stroke has been excluded, the risk of bleeding (hemorrhagic transformation of stroke or bleeding into another site) is assessed to be low, and who have one or more of the following: • major restriction of mobility • previous history of VTE • dehydration or comorbidities (such as malignant disease).Age: 55-80 years)

You may not qualify if:

• Obese (\>150 KG)
• Suffer from renal insufficiency (ccl\<30)

Sponsors & Collaborators

• Loewenstein Hospital: lead
• Meir Medical Center: collaborator

Study Sites (1)

Loewenstein Hospital

Raanana, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Motti Ratmansky, MD

  Loewenstein Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Motti Ratmansky, MD

CONTACT

+97297709102; mottir@clalit.org.il

Deborah Rubin-Asher, MD

CONTACT

+97297709164; dasher@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: November 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)