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IRCT20240929063203N4 IRCT 2025-12-20 Bandare-abbas University of Medical Sciences Comparison of Subcutaneous and Intravenous Heparin Administration Methods for the Prevention of Venous Thromboembolism in the Intensive Care Unit VTE Comparison of Subcutaneous and Intravenous Heparin Administration Methods for the Prevention of Venous Thromboembolism in the Intensive Care Unit 2025-12-25 anticipated 106 Complete https://irct.ir/trial/88173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This clinical trial will use simple randomization with an individual randomization unit. Patients admitted to the intensive care unit (ICU) of Shahid Mohammadi Hospital, Bandar Abbas, who are eligible based on inclusion criteria (such as ICOPER criteria and no contraindication to heparin), will be allocated in a 1:1 ratio to two groups of subcutaneous heparin injection (5000 units/m2, twice daily) and intravenous heparin injection (5000 units/m2, twice daily). Random Allocation Software was used to generate the randomization sequence. Allocation concealment is ensured through segregation of responsibilities of the research team (separation of the enroller from the allocator), limited access control to the randomization sequence, and complete documentation of the process to minimize the possibility of selection bias, Blinding description: This study is a double-blind clinical trial in which patients, ICU attending physicians, nursing staff (except the injecting nurse), and outcome assessors (including the person performing the Doppler ultrasound, the clinical assessment of VTE symptoms, and the final judgment of VTE diagnosis) will be unaware of the prescribed heparin injection method (subcutaneous or intravenous) and patient allocation group. Preparation and administration of drugs will be performed by the injecting nurse who is not involved in the outcome assessment and clinical judgment. Heparin vials and syringes are provided with coded labels (A or B) without indicating the actual injection method. The allocation code will be kept in sealed envelopes and will not be opened until the end of the study and the completion of data analysis, except in emergencies. Data collection is performed by a research assistant or independent nurse who is unaware of patient allocation, and only the nurse responsible for preparing and administering the drug and the person responsible for randomization (who are not involved in enrollment and outcome assessment) will be aware of the allocation. This design minimizes the potential for performance bias and detection bias. 3 Venous thromboembolism. Intervention 1: Intervention group 1: Patients admitted to the ICU received 5000 units of non-fractionated heparin subcutaneously every 12 hours; the infusion began on the day of study entry and continued for at least 7 days or until discharge. Intervention 2: Second intervention group: Patients received unfractionated heparin with an initial bolus of 5000 intravenous units followed by continuous infusion (dose adjustment based on target aPTT of 1.5-2.5 times normal every 6 hours); duration similar to the first group. No - There is not a plan to make this available Justification or reason for not sharing IPD is En Still undecided - no release schedule yet.
public Majid Vatankhah
Next to Recovery, 5-story Building, First Floor, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 hormozgan91@yahoo.com Bandare-abbas University of Medical Sciences scientific Mehrdad Malekshoar
Next to Recovery, 5-story building, first floor, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 mdmalekshoar@yahoo.com‏ Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Individuals aged 18 to 70 years Use of vasopressors Use of a central venous catheter Patients with platelet transfusions Patients with previous Venous Thromboembolism 18 years 70 years Both Patients who develop heparin-induced thrombocytopenia (HIT) after starting treatment. Patients who experience bleeding at the surgical site or intracerebral bleeding (including epidural hematoma, subdural hematoma, intracerebral hemorrhage, and hemorrhagic stroke). Patients who require surgery for any reason; in these cases, heparin is discontinued 6 hours before surgery and the patient is excluded from the study. 180.1 I80.1: Phlebitis and thrombophlebitis of femoral vein Treatment - Drugs Treatment - Drugs Intervention group 1: Patients admitted to the ICU received 5000 units of non-fractionated heparin subcutaneously every 12 hours; the infusion began on the day of study entry and continued for at least 7 days or until discharge. Second intervention group: Patients received unfractionated heparin with an initial bolus of 5000 intravenous units followed by continuous infusion (dose adjustment based on target aPTT of 1.5-2.5 times normal every 6 hours); duration similar to the first group. Occurrence of venous thromboembolism during intensive care unit hospitalization, based on clinical diagnosis and confirmed by imaging modalities (Doppler ultrasonography or computed tomography angiography). Timepoint: From admission to discharge from the intensive care unit. Method of measurement: Clinical assessment by the attending physician with diagnostic confirmation using Doppler ultrasonography or computed tomography angiography. Changes in platelet count. Timepoint: Baseline (day 0), day 3, and day 7 of intensive care unit hospitalization. Method of measurement: Laboratory measurement of platelet count using a venous blood sample; unit: ×1000/μL. Changes in prothrombin time. Timepoint: Baseline (day 0), day 3, and day 7 of intensive care unit hospitalization. Method of measurement: Laboratory measurement of prothrombin time using a venous blood sample; unit: seconds. Changes in international normalized ratio. Timepoint: Baseline (day 0), day 3, and day 7 of intensive care unit hospitalization. Method of measurement: Laboratory measurement of international normalized ratio using a venous blood sample; unitless. Changes in activated partial thromboplastin time. Timepoint: Baseline (day 0), day 3, and day 7 of intensive care unit hospitalization. Method of measurement: Laboratory measurement of activated partial thromboplastin time using a venous blood sample; unit: seconds. Occurrence of major bleeding during intensive care unit hospitalization. Timepoint: From admission to discharge from the intensive care unit. Method of measurement: Clinical evaluation by the attending physician and review of medical records based on standard criteria for major bleeding (including a decrease in hemoglobin level, need for blood transfusion, or bleeding at critical sites). Occurrence of thrombocytopenia. Timepoint: Baseline (day 0), day 3, and day 7 of intensive care unit hospitalization. Method of measurement: Laboratory measurement of platelet count using a venous blood sample; thrombocytopenia defined as a platelet count below the institutional reference range. Length of intensive care unit stay. Timepoint: At discharge from the intensive care unit. Method of measurement: Calculation of the duration of intensive care unit hospitalization based on medical records; unit: days. Mortality. Timepoint: From admission to discharge from the intensive care unit. Method of measurement: Assessment of survival status through medical records during intensive care unit hospitalization. Difference in lower limb circumference. Timepoint: Baseline (day 0), day 3, and day 7 of intensive care unit hospitalization. Method of measurement: Measurement of lower limb circumference using a measuring tape at predefined anatomical landmarks; unit: centimeters. Bandare-abbas University of Medical Sciences Approved 2023-02-19 Research Ethics Committees of Hormozgan University of Medical Sciences Shahid Chamran Boulevard Bandar Abbas Hormozgan Iran (Islamic Republic of)