drugset / Trial / NCT03465085

Streptokinase Versus Unfractionated Heparin Nebulization in Severe ARDS

NCT03465085

Phase 3 Completed 60 enrolled Beni-Suef University
RandomizedFactorialTriple-blindTreatment

Summary

Background: Intra-alveolar clotting and alveolar collapse in ARDS is due to alveolar capillaries epithelial and leakage. Subsequently, collapse induces hypoxemia that is resistant to recruitment (RM). Heparin and Streptokinase may prevent or dissolve intra-alveolar fibrin clot respectively helping alveolar re-expansion. We examined and compared the effect of nebulizing Heparin versus Streptokinase on reversing this pathology. Methods: Sixty severe ARDS (PaO2/FiO2\<100) patients and failure of RM, prone position (PP) and neuromuscular block (NMB) were partially randomised into Group (I): (n=20) received nebulized Heparin 10000 IU/4h. Group (II): (n=20) received nebulized Streptokinase 250,000 IU/4h. Group (III): (n=20) received conservative management. Randomization to either Heparin or Streptokinase groups was applied to patients whom guardian accepted participation, while those who declined participation were followed-up as a control. The primary outcome was the change in PaO2/FiO2; the secondary outcomes included the change in compliance, plateau pressure, ventilation-off days, coagulation and ICU mortality.

Timeline

Start
2016-02-18
Primary completion
2018-01-30
Completion
2018-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Heparin Other / unclassified 10000 iu Inhaled
Subject Streptokinase Protein / enzyme biologic 250000 iu Inhaled