Protocol summary
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Study aim
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Evaluation of efficacy and safety of apixaban the treatment of heparin-induced thrombocytopenia (HIT)
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Design
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Clinical trial, without control group, sample size of 30 patients, phase 2
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Follow-up of venous and arterial thrombosis
Assessment of side effects including bleeding in various organs
Mortality rate
General information
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Reason for update
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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.
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Acronym
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HIT
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IRCT registration information
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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
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Registration date
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2021-04-25, 1400/02/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-22, 1400/03/01
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Expected recruitment end date
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2021-07-23, 1400/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the efficacy of apixaban in the treatment of heparin-induced thrombocytopenia (HIT)
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Public title
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Apixaban in heparin-induced thrombocytopenia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-01, 1399/08/11
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Ethics committee reference number
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IR.IUMS.REC.1399.733
Health conditions studied
1
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Description of health condition studied
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Heparin-induced thrombocytopenia
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ICD-10 code
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D69.6
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ICD-10 code description
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Thrombocytopenia, unspecified
Primary outcomes
1
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Description
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Follow-up of arterial / venous thrombosis after receiving apixaban
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Timepoint
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If the patient becomes symptomatic
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Method of measurement
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Doppler ultrasound
Secondary outcomes
1
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Description
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Mortality rate
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Timepoint
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Daily
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Method of measurement
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Loss of vital signs and death of the patient
2
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Description
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Bleeding event following the use of apixaban
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Timepoint
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Daily
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Method of measurement
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Based on the patient's symptoms such as petechiae
Intervention groups
1
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Description
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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.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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As an article
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When the data will become available and for how long
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08-23-2021
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Eligible individuals can access patient data upon written request.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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By email to responsible people
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Comments
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