T A Halim1, H S Chhabra1, M Arora2, S Kumar1. 1. Spine Service, Indian Spinal Injuries Centre, New Delhi, India. 2. Research Department, Indian Spinal Injuries Centre, New Delhi, India.
Abstract
STUDY DESIGN: Prospective randomized single blind study. OBJECTIVES: To find out the incidence of deep vein thrombosis (DVT) in Indian acute spinal cord injury (ASCI) subjects with and without pharmacological prophylaxis. SETTING:Indian Spinal Injuries Centre. METHODS:Seventy four ASCI subjects were randomly divided into two groups with 37 subjects each: group I received no antithrombotic prophylaxis, and only physical measures like compression stockings were employed for prophylaxis, whereas group II received antithrombotic prophylaxis with low-molecular weight heparin (LMWH) along with physical measures as in group I. DVT was monitored through daily clinical assessment and doppler venous ultrasonography at 2 weeks. RESULTS: Out of 37 subjects in each group, eight (21.6%) developed DVT in group I and two (5.4%) in group II. The difference was significant (P-value=0.041). Six out of eight subjects who developed DVT in group I were asymptomatic. There was no incidence of significant DVT-related complications including pulmonary embolism in any of the subjects. CONCLUSIONS: There is a significant incidence of DVT in Indian subjects with ASCI but definitely less than what has been reported in western literature. Pharmacological prophylaxis (LMWH in this study) significantly (P=0.041) decreases the incidence of DVT in subjects with ASCI. As there was no difference in the incidence of symptomatic DVT or related complications, a larger study would be required to conclude definitely on the role of pharmacological prophylaxis in the Indian population.
RCT Entities:
STUDY DESIGN: Prospective randomized single blind study. OBJECTIVES: To find out the incidence of deep vein thrombosis (DVT) in Indian acute spinal cord injury (ASCI) subjects with and without pharmacological prophylaxis. SETTING: Indian Spinal Injuries Centre. METHODS: Seventy four ASCI subjects were randomly divided into two groups with 37 subjects each: group I received no antithrombotic prophylaxis, and only physical measures like compression stockings were employed for prophylaxis, whereas group II received antithrombotic prophylaxis with low-molecular weight heparin (LMWH) along with physical measures as in group I. DVT was monitored through daily clinical assessment and doppler venous ultrasonography at 2 weeks. RESULTS: Out of 37 subjects in each group, eight (21.6%) developed DVT in group I and two (5.4%) in group II. The difference was significant (P-value=0.041). Six out of eight subjects who developed DVT in group I were asymptomatic. There was no incidence of significant DVT-related complications including pulmonary embolism in any of the subjects. CONCLUSIONS: There is a significant incidence of DVT in Indian subjects with ASCI but definitely less than what has been reported in western literature. Pharmacological prophylaxis (LMWH in this study) significantly (P=0.041) decreases the incidence of DVT in subjects with ASCI. As there was no difference in the incidence of symptomatic DVT or related complications, a larger study would be required to conclude definitely on the role of pharmacological prophylaxis in the Indian population.
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