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Comparison of Subcutaneous and Intravenous Heparin Administration Methods for the Prevention of Venous Thromboembolism in the Intensive Care Unit

Comparison of Subcutaneous and Intravenous Heparin Administration Methods for the Prevention of Venous Thromboembolism in the Intensive Care Unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240929063203N4
Enrollment
106
Registered
2025-12-20
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thromboembolism. I80.1: Phlebitis and thrombophlebitis of femoral vein

Interventions

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 b
duration similar to the first group.

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Individuals aged 18 to 70 years Use of vasopressors Use of a central venous catheter Patients with platelet transfusions Patients with previous Venous Thromboembolism

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Vatankhah

Bandare-abbas University of Medical Sciences

hormozgan91@yahoo.com+98 76 3334 5009

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026