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Evaluation of the efficacy of apixaban in the treatment of heparin-induced thrombocytopenia (HIT)

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History
# Registration date Revision Id
2 2021-05-17, 1400/02/27 183952
1 2021-04-25, 1400/02/05 180130
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  • Protocol summary

    In patients admitted to the internal ward of Rasool Akram Hospital who are diagnosed with HIT by the 4T Score, heparin will be discontinued and apixaban will be started. Dosage in the diagnosis of DVT and PE 10 mg twice daily for 7 days and then 5 mg twice daily, in prophylactic use 2.5 mg twice daily and in patients with non-valvular atrial fibrillation dose 5 mg twice daily will be used.
    In patients admitted to the internal ward of Rasool Akram Hospital who are diagnosed with HIT by the 4T Score, heparin will be discontinued and apixaban will be started. Based on some evidences, the dose of apixaban for the treatment of HIT is 10 mg/BD for 7 days followed by 5 mg twice daily; so we will use mentioned dose in the treatment of DVT or PE and in the prevention of stroke in non-valvular َAF. In prophylactic setting, we will use a dose of 2.5 mg twice a day, unless the patient experienced HIT with thrombosis that will receive apixaban in treatment dose of HIT.
    در بیماران بستری در بخش داخلی بیمارستان رسول اکرم که از طریق 4T Score تشخیص HIT دارند، هپارین قطع و اپکسیبان شروع خواهد شد. دوز در تشخیص DVT و PE ده میلی گرم دو بار در روز به مدت 7 روز و به دنبال 5 میلی گرم دو بار در روز، در استفاده پروفیلاکتیک دوز 2.5 میلی گرم دو بار در روز و در بیماران دچار فیبریلاسیون دهلیزی غیر دریچه ای دوز 5 میلی گرم دو بار خواهد بود.
    در بیماران بستری در بخش داخلی بیمارستان رسول اکرم که از طریق 4T Score تشخیص HIT دارند، هپارین قطع و اپکسیبان شروع خواهد شد. بر اساس برخی شواهد ، دوز آپیکسابان برای درمان HIT، ده میلی گرم BD به مدت 7 روز و به دنبال آن 5 میلی گرم دو بار در روز است.بنابراین ما از دوز ذکر شده در درمان DVT یا PE و جلوگیری از سکته در AF غیر دریچه ای استفاده خواهیم کرد.در شرایط پیشگیری ، از دوز 2.5 میلی گرم دو بار در روز استفاده خواهیم کرد ، مگر اینکه بیمار HIT را با ترومبوز تجربه کند که در دوز درمانی HIT ، آپیکسابان دریافت خواهد کرد.
    Inclusion criteria: 1) Age 18 years or older 2) HIT detection based on 4T Score equal to or greater than 4 Non-inclusion criteria: 1) Patients with active bleeding 2) Hereditary or acquired coagulation disease or bleeding disorder 3) Receiving cytochrome P-450 3A4 inhibitor or inducer compounds 4) Severe renal failure (CrCl <25 ml / min) 5) Severe liver disease (including Child-Pugh B and C) 6) The patient needs surgery 7) History of unmodified cerebral aneurysm, intracranial tumor or vascular accident 8) Not participating in another study during the last 30 days 9) Pregnant and lactating women 10) Previous treatment with a non-heparin anticoagulant
    Inclusion criteria: 1) Age 18 years or older 2) HIT detection based on 4T Score equal to or greater than 4 Non-inclusion criteria: 1) Patients with active bleeding 2) Hereditary or acquired coagulation disease or bleeding disorder 3) Receiving cytochrome P-450 3A4 inhibitor or inducer compounds 4) Severe renal failure (CrCl <25 ml / min) 5) Severe liver disease 6) The patient needs surgery 7) History of unmodified cerebral aneurysm, intracranial tumor or vascular accident 8) Not participating in another study during the last 30 days 9) Pregnant and lactating women 10) Previous treatment with a non-heparin anticoagulant 11) Covid-19 Infection
    معیارهای ورود به مطالعه : 1) سن 18 سال یا بالاتر 2) تشخیص HIT بر اساس 4T Score مساوی یا بالاتر از 4 معیارهای عدم ورود به مطالعه 1) بیماران دچار خونریزی فعال 2) بیماری انعقادی ارثی یا اکتسابی یا اختلال خونریزی دهنده 3) دریافت ترکیبات مهار کننده یا القا کننده سیتوکروم P-450 3A4 4) نارسایی شدید کلیوی (CrCl <25 ml / min) 5) بیماری کبدی شدید (از جمله Child-Pugh B و C) 6) بیمار نیازمند به عمل جراحی 7) سابقه آنوریسم مغزی اصلاح نشده ، تومور داخل جمجمه یا حادثه عروقی 8) عدم شرکت در مطالعه دیگر در طی 30 روز گذشته 9) زنان باردار و شیرده 10) درمان قبلی با یک ضد انعقاد غیر هپارین
    معیارهای ورود به مطالعه : 1) سن 18 سال یا بالاتر 2) تشخیص HIT بر اساس 4T Score مساوی یا بالاتر از 4 معیارهای عدم ورود به مطالعه 1) بیماران دچار خونریزی فعال 2) بیماری انعقادی ارثی یا اکتسابی یا اختلال خونریزی دهنده 3) دریافت ترکیبات مهار کننده یا القا کننده سیتوکروم P-450 3A4 4) نارسایی شدید کلیوی (CrCl <25 ml / min) 5) بیماری کبدی شدید 6) بیمار نیازمند به عمل جراحی 7) سابقه آنوریسم مغزی اصلاح نشده ، تومور داخل جمجمه یا حادثه عروقی 8) عدم شرکت در مطالعه دیگر در طی 30 روز گذشته 9) زنان باردار و شیرده 10) درمان قبلی با یک ضد انعقاد غیر هپارین 11) بیماران مبتلا به کووید 19
    Thirty patients with heparin-induced thrombocytopenia or low molecular weight heparin, such as enoxaparin, will be screened for inclusion. Use of heparin, including non-valvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, and anticoagulant prophylaxis during hospitalization will be considered.
    Thirty patients with heparin-induced thrombocytopenia will be screened for inclusion. Use of heparin, including non-valvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, and anticoagulant prophylaxis during hospitalization will be considered.
    30 بیمار دچار ترومبوسیتوپنی ناشی از هپارین یا هپارین با وزن مولکولی پایین مثل انوکساپارین، با شرایط ورود مطالعه بررسی خواهند شد. موارد مصرف هپارین از جمله فیبریلاسیون دهلیزی غیر دریچه ای، ترومبوز ورید عمقی ، آمبولی ریوی ، دریافت انتی کواگولانت به صورت پروفیلاکتیک در طی دوره بستری در بیمارستان در نظر گرفته خواهد شد.
    30 بیمار دچار ترومبوسیتوپنی ناشی از هپارین، با شرایط ورود مطالعه بررسی خواهند شد. موارد مصرف هپارین از جمله فیبریلاسیون دهلیزی غیر دریچه ای، ترومبوز ورید عمقی ، آمبولی ریوی ، دریافت انتی کواگولانت به صورت پروفیلاکتیک در طی دوره بستری در بیمارستان در نظر گرفته خواهد شد.
    Duration of platelet increase above 150,000 after receiving Apixaban Follow-up of venous and arterial thrombosis Assessment of side effects including bleeding in various organs Mortality rate
    Follow-up of venous and arterial thrombosis Assessment of side effects including bleeding in various organs Mortality rate
    مدت زمان افزایش پلاکت به بالای 150000 بعد از دریافت اپکسبیان پیگیری ترومبوز وریدی و شریانی ارزیابی عوارض جانبی شامل خونریزی در ارگان های مختلف میزان مورتالیته
    پیگیری ترومبوز وریدی و شریانی ارزیابی عوارض جانبی شامل خونریزی در ارگان های مختلف میزان مورتالیته

  • General information

    empty
    Due to updates regarding the dose of Apixaban, therapeutic intervention needs to be changed. In addition, in this study, patients with Covid-19 will not be included in the study.
    empty
    با توجه به اپدیت های انجام شده در خصوص دوز Apixaban، مداخله درمانی نیاز به تغییر دارد. به همین ترتیب در این مطالعه بیماران مبتلا به کووید 19 وارد مطالعه نخواهند شد.
    Patients with active bleeding
    Patient with inherited or acquired coagulation disease or bleeding disorder
    Patients receiving cytochrome P-450 3A4 inhibitors or inducers
    Severe renal failure (CrCl <25 ml / min)
    Severe liver disease (including Child-Pugh B and C)
    The patient needs surgery
    History of uncorrected cerebral aneurysm, intracranial tumor or vascular accident
    Non-participation in research projects during the 30 days prior to the study
    Pregnant and lactating women
    Previous treatment with a non-heparin anticoagulant
    Patients with active bleeding
    Patient with inherited or acquired coagulation disease or bleeding disorder
    Patients receiving cytochrome P-450 3A4 inhibitors or inducers
    Severe renal failure (CrCl <25 ml / min)
    Severe liver disease (including Child-Pugh B and C)
    The patient needs surgery
    History of uncorrected cerebral aneurysm, intracranial tumor or vascular accident
    Non-participation in research projects during the 30 days prior to the study
    Pregnant and lactating women
    Previous treatment with a non-heparin anticoagulant
    Covid-19 infection
    بیماران دچار خونریزی فعال
    بیمار دارای بیماری انعقادی ارثی یا اکتسابی یا اختلال خونریزی دهنده
    بیماران دریافت کننده ترکیبات مهار کننده یا القا کننده سیتوکروم P-450 3A4
    نارسایی شدید کلیوی (CrCl <25 ml / min)
    بیماری کبدی شدید (از جمله Child-Pugh B و C)
    بیمار نیازمند به عمل جراحی
    سابقه آنوریسم مغزی اصلاح نشده ، تومور داخل جمجمه یا حادثه عروقی
    عدم شرکت در طرح های تحقیقاتی در طی 30 روز قبل از مطالعه مذکور
    زنان باردار و شیرده
    درمان قبلی با یک ضد انعقاد غیر هپارین
    بیماران دچار خونریزی فعال
    بیمار دارای بیماری انعقادی ارثی یا اکتسابی یا اختلال خونریزی دهنده
    بیماران دریافت کننده ترکیبات مهار کننده یا القا کننده سیتوکروم P-450 3A4
    نارسایی شدید کلیوی (CrCl <25 ml / min)
    بیماری کبدی شدید (از جمله Child-Pugh B و C)
    بیمار نیازمند به عمل جراحی
    سابقه آنوریسم مغزی اصلاح نشده ، تومور داخل جمجمه یا حادثه عروقی
    عدم شرکت در طرح های تحقیقاتی در طی 30 روز قبل از مطالعه مذکور
    زنان باردار و شیرده
    درمان قبلی با یک ضد انعقاد غیر هپارین
    بیماران مبتلا به کووید 19

  • Primary outcomes

    #1
    Duration of platelet increase above 150,000 after receiving Apixaban
    Follow-up of arterial / venous thrombosis after receiving apixaban
    مدت زمان افزایش پلاکت به بالای 150000 بعد از دریافت اپکسبیان
    پیگیری بروز ترومبوز شریانی / وریدی بعد از دریافت اپکسبیان
    Daily
    If the patient becomes symptomatic
    روزانه
    در صورت علامتدار شدن بیمار
    CBC Test
    Doppler ultrasound
    آزمایش CBC
    سونوگرافی داپلر
    #2
    Follow-up of arterial / venous thrombosis after receiving apixaban
    empty
    پیگیری بروز ترومبوز شریانی / وریدی بعد از دریافت اپکسبیان
    empty
    If the patient becomes symptomatic
    empty
    در صورت علامتدار شدن بیمار
    empty
    Doppler ultrasound
    empty
    سونوگرافی داپلر
    empty
    #3
    Bleeding event following the use of apixaban
    empty
    بروز خونریزی ها به دنبال مصرف اپکسبیان
    empty
    Daily
    empty
    روزانه
    empty
    Based on the patient's symptoms such as petechiae
    empty
    بر اساس علایم بیمار مثل پتشی
    empty

  • Secondary outcomes

    #1
    Mortality reate
    Mortality rate
    #2
    empty
    Bleeding event following the use of apixaban
    empty
    بروز خونریزی ها به دنبال مصرف اپکسبیان
    empty
    Daily
    empty
    روزانه
    empty
    Based on the patient's symptoms such as petechiae
    empty
    بر اساس علایم بیمار مثل پتشی

  • Intervention groups

    #1
    Intervention group: In patients admitted to the internal ward of Rasool Akram Hospital who are diagnosed with HIT by the 4T Score, heparin will be discontinued and apixaban will be started. Dosage in the diagnosis of DVT and PE 10 mg twice daily for 7 days and then 5 mg twice daily, in prophylactic use 2.5 mg twice daily and in patients with non-valvular atrial fibrillation dose 5 mg twice daily will be used
    Intervention group: In patients admitted to the internal ward of Rasool Akram Hospital who are diagnosed with HIT by the 4T Score, heparin will be discontinued and apixaban will be started. Based on some evidences, the dose of apixaban for the treatment of HIT is 10 mg/BD for 7 days followed by 5 mg twice daily; so we will use mentioned dose in the treatment of DVT or PE and in the prevention of stroke in non-valvular َAF. In prophylactic setting, we will use a dose of 2.5 mg twice a day, unless the patient experienced HIT with thrombosis that will receive apixaban in treatment dose of HIT.
    گروه مداخله: در بیماران بستری در بخش داخلی بیمارستان رسول اکرم که از طریق 4T Score تشخیص HIT دارند، هپارین قطع و اپکسیبان شروع خواهد شد. دوز در تشخیص DVT و PE ده میلی گرم دو بار در روز به مدت 7 روز و به دنبال 5 میلی گرم دو بار در روز، در استفاده پروفیلاکتیک دوز 2.5 میلی گرم دو بار در روز و در بیماران دچار فیبریلاسیون دهلیزی غیر دریچه ای دوز 5 میلی گرم دو بار خواهد بود.
    گروه مداخله: در بیماران بستری در بخش داخلی بیمارستان رسول اکرم که از طریق 4T Score تشخیص HIT دارند، هپارین قطع و اپکسیبان شروع خواهد شد. بر اساس برخی شواهد ، دوز آپیکسابان برای درمان HIT، ده میلی گرم BD به مدت 7 روز و به دنبال آن 5 میلی گرم دو بار در روز است.بنابراین ما از دوز ذکر شده در درمان DVT یا PE و جلوگیری از سکته در AF غیر دریچه ای استفاده خواهیم کرد.در شرایط پیشگیری ، از دوز 2.5 میلی گرم دو بار در روز استفاده خواهیم کرد ، مگر اینکه بیمار HIT را با ترومبوز تجربه کند که در دوز درمانی HIT ، آپیکسابان دریافت خواهد کرد.

Protocol summary

Study aim
Evaluation of efficacy and safety of apixaban the treatment of heparin-induced thrombocytopenia (HIT)
Design
Clinical trial, without control group, sample size of 30 patients, phase 2
Settings and conduct
In patients admitted to the internal ward of Rasool Akram Hospital who are diagnosed with HIT by the 4T Score, heparin will be discontinued and apixaban will be started. Based on some evidences, the dose of apixaban for the treatment of HIT is 10 mg/BD for 7 days followed by 5 mg twice daily; so we will use mentioned dose in the treatment of DVT or PE and in the prevention of stroke in non-valvular َAF. In prophylactic setting, we will use a dose of 2.5 mg twice a day, unless the patient experienced HIT with thrombosis that will receive apixaban in treatment dose of HIT.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Age 18 years or older 2) HIT detection based on 4T Score equal to or greater than 4 Non-inclusion criteria: 1) Patients with active bleeding 2) Hereditary or acquired coagulation disease or bleeding disorder 3) Receiving cytochrome P-450 3A4 inhibitor or inducer compounds 4) Severe renal failure (CrCl <25 ml / min) 5) Severe liver disease 6) The patient needs surgery 7) History of unmodified cerebral aneurysm, intracranial tumor or vascular accident 8) Not participating in another study during the last 30 days 9) Pregnant and lactating women 10) Previous treatment with a non-heparin anticoagulant 11) Covid-19 Infection
Intervention groups
Thirty patients with heparin-induced thrombocytopenia will be screened for inclusion. Use of heparin, including non-valvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, and anticoagulant prophylaxis during hospitalization will be considered.
Main outcome variables
Follow-up of venous and arterial thrombosis Assessment of side effects including bleeding in various organs Mortality rate

General information

Reason for update
Due to updates regarding the dose of Apixaban, therapeutic intervention needs to be changed. In addition, in this study, patients with Covid-19 will not be included in the study.
Acronym
HIT
IRCT registration information
IRCT registration number: IRCT20200325046854N1
Registration date: 2021-04-25, 1400/02/05
Registration timing: prospective

Last update: 2021-05-25, 1400/03/04
Update count: 1
Registration date
2021-04-25, 1400/02/05
Registrant information
Name
Maryam Farasatinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 4800
Email address
maryfarasati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of apixaban in the treatment of heparin-induced thrombocytopenia (HIT)
Public title
Apixaban in heparin-induced thrombocytopenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age 18 years or older 2) HIT detection based on 4T Score equal to or above 4
Exclusion criteria:
Patients with active bleeding Patient with inherited or acquired coagulation disease or bleeding disorder Patients receiving cytochrome P-450 3A4 inhibitors or inducers Severe renal failure (CrCl <25 ml / min) Severe liver disease (including Child-Pugh B and C) The patient needs surgery History of uncorrected cerebral aneurysm, intracranial tumor or vascular accident Non-participation in research projects during the 30 days prior to the study Pregnant and lactating women Previous treatment with a non-heparin anticoagulant Covid-19 infection
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.IUMS.REC.1399.733

Health conditions studied

1

Description of health condition studied
Heparin-induced thrombocytopenia
ICD-10 code
D69.6
ICD-10 code description
Thrombocytopenia, unspecified

Primary outcomes

1

Description
Follow-up of arterial / venous thrombosis after receiving apixaban
Timepoint
If the patient becomes symptomatic
Method of measurement
Doppler ultrasound

Secondary outcomes

1

Description
Mortality rate
Timepoint
Daily
Method of measurement
Loss of vital signs and death of the patient

2

Description
Bleeding event following the use of apixaban
Timepoint
Daily
Method of measurement
Based on the patient's symptoms such as petechiae

Intervention groups

1

Description
Intervention group: In patients admitted to the internal ward of Rasool Akram Hospital who are diagnosed with HIT by the 4T Score, heparin will be discontinued and apixaban will be started. Based on some evidences, the dose of apixaban for the treatment of HIT is 10 mg/BD for 7 days followed by 5 mg twice daily; so we will use mentioned dose in the treatment of DVT or PE and in the prevention of stroke in non-valvular َAF. In prophylactic setting, we will use a dose of 2.5 mg twice a day, unless the patient experienced HIT with thrombosis that will receive apixaban in treatment dose of HIT.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
of Rasool Akram Hospital
Full name of responsible person
Somayyeh Nasiripour
Street address
Niyayesh St, Sattar Khan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
nasiripours@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Farasatinasab
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8214 1000
Email
maryfarasati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Farasatinasab
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8214 1000
Email
maryfarasati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayyeh Nasiripour
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh St, Sattar khan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
nasiripours@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
As an article
When the data will become available and for how long
08-23-2021
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Eligible individuals can access patient data upon written request.
From where data/document is obtainable
Somayyeh Nasiripour, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences Email: nasiripours@yahoo.com Maryam Farasatinasab, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences Email: maryfarasati@gmail.com
What processes are involved for a request to access data/document
By email to responsible people
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