StrokeNCT03593291
LMWH-VTE Prophylaxis for Survivors of Acute Ischemic Stroke- Assessment of Standard Dosing Regimen
An observational study of Stroke, run by Loewenstein Hospital at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Anti Xa
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients hospitalized for rehabilitation following acute ischemic stroke in 2018
Who may be able to join
- 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)
Who cannot join
- Obese (>150 KG)
- Suffer from renal insufficiency (ccl<30)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Loewenstein Hospital
Raanana
Moti Ratmansky, MD, 97297709907, MottiR@clalit.org.il
Deborah Asher, MD, 97297709164, dasher@clalit.org.il
About this study
Official title: Anti Xa Blood Levels at Survivors of Acute Ischemic Stroke- Receiving LMWH-VTE Prophylaxis
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.
Read the detailed description
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.
Purpose To perform an exploratory prospective analysis of longitudinal data sets to assess anti-factor Xa levels in a cohort of patients recovering from acute ischemic stroke and receiving prophylactic-dose LMWH for VTE prevention.
Primary Outcome Measures:
- assess anti-factor Xa levels
- adverse events related to thrombosis
- adverse event related to hemorrhage
Secondary Outcome Measures:
Patient demographic data Patient anthropometric data Adverse events/weekly (falls, infections, VTE, stress ulcer…) Eligibility
Ages Eligible for Study: 40 Years to 80 Years (Adult, Senior) Gender Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Study Population Patients hospitalized for rehabilitation following acute ischemic stroke
Methods:
Clinical decision to administer LMWH prophylactic treatment will be made in line with standard clinical practice and in accordance to the criteria described above.
Search for patients diagnosed with sub-acute stroke and receiving LMWH treatment will be performed on the digital database of the Loewenstien rehabilitation hospital Rannana, Israel.
Patients receiving LMWH prophylaxis with fixed dose regimen will be recruited flowing signing of consent form.
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. In the event of high or low results the Hematological consult will be contacted for decision about dose adjustment or other intervention/investigation.
All data will be drawn from patient's electronic/hardcopy files. patient characteristics (age, gender, , past medical history), Stroke characteristics (type, location, NIHSS), days from stroke onset to rehabilitation admission, along with each patient's length of stay, neurological impairments, and Rehabilitation outcomes. Trained research associates, who are familiar with the process of chart review, will extract the information from the charts using the form provided.
Statistical analysis: multi variant combative analysis of outcome measures will be carried out to compare study and control groups.
Estimated Enrollment: 100 patients
- Conditions
- Stroke
- Being tested
- Anti Xa
- Keywords
- Stroke, VTE prophylaxis, Anti Xa
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti XaDiagnostic test
Levels of Anti Xa measure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 hours post LMWH administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Nov 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Meir Medical Center
- Responsible party
- Principal investigator, Motti Ratmansky, MD, Loewenstein Hospital
- Investigators
- Motti Ratmansky, MD, Principal investigator, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593291
- Sponsor's protocol ID
- 0022-17-LOE
- Status last verified
- Aug 2018
- First submitted
- 10 Jul 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Xa Blood Levels at Survivors of Acute Ischemic Stroke- Receiving LMWH-VTE Prophylaxis
- ClinicalTrials.gov ID
- NCT03593291
- Acronym / sponsor ID
- 0022-17-LOE
- Conditions
- Stroke
- Keywords
- Stroke, VTE prophylaxis, Anti Xa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- Meir Medical Center
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Purpose To perform an exploratory prospective analysis of longitudinal data sets to assess anti-factor Xa levels in a cohort of patients recovering from acute ischemic stroke and receiving prophylactic-dose LMWH for VTE prevention.
Primary Outcome Measures:
- assess anti-factor Xa levels
- adverse events related to thrombosis
- adverse event related to hemorrhage
Secondary Outcome Measures:
Patient demographic data Patient anthropometric data Adverse events/weekly (falls, infections, VTE, stress ulcer…) Eligibility
Ages Eligible for Study: 40 Years to 80 Years (Adult, Senior) Gender Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Study Population Patients hospitalized for rehabilitation following acute ischemic stroke
Methods:
Clinical decision to administer LMWH prophylactic treatment will be made in line with standard clinical practice and in accordance to the criteria described above.
Search for patients diagnosed with sub-acute stroke and receiving LMWH treatment will be performed on the digital database of the Loewenstien rehabilitation hospital Rannana, Israel.
Patients receiving LMWH prophylaxis with fixed dose regimen will be recruited flowing signing of consent form.
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. In the event of high or low results the Hematological consult will be contacted for decision about dose adjustment or other intervention/investigation.
All data will be drawn from patient's electronic/hardcopy files. patient characteristics (age, gender, , past medical history), Stroke characteristics (type, location, NIHSS), days from stroke onset to rehabilitation admission, along with each patient's length of stay, neurological impairments, and Rehabilitation outcomes. Trained research associates, who are familiar with the process of chart review, will extract the information from the charts using the form provided.
Statistical analysis: multi variant combative analysis of outcome measures will be carried out to compare study and control groups.
Estimated Enrollment: 100 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for rehabilitation following acute ischemic stroke in 2018
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Obese (>150 KG)
- Suffer from renal insufficiency (ccl<30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti XaLevels of Anti Xa measure | Diagnostic test | – |
Primary outcome
Anti-Xa level
Time frame: 3-4 hours post LMWH administration
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Motti Ratmansky, MD principal investigator
Loewenstein Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Motti Ratmansky, MD (+97297709102, mottir@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Xa level (time frame: 3-4 hours post LMWH administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.