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Fibrinolytic treatment of acute respiratory failure due to inflammatory lung injury

Fibrinolytic treatment of acute respiratory failure due to inflammatory lung injury to assess improvement in alveolar dead space and right ventricular function

Sponsor

St Vincent's Hospital

Enrollment

12 participants

Start Date

Dec 12, 2010

Study Type

Interventional

Conditions

acute respiratory failure due to inflammatory lung injury

Summary

Inflammatory insults including pneumonia, sepsis, aspiration, trauma, prolonged hypotension, cardiac surgery and pancreatitis can cause lung damage. One mechanism by which inflammation mediates lung injury is through deposition of fibrin in the pulmonary microcirculation. This study will investigate if limiting fibrin deposition through administration of tissue plasminogen activator reduces lung damage.

Eligibility

Sex: Both males and femalesMin Age: 15 Yearss

Inclusion Criteria5

  • Patients with acute respiratory failure due to an acute inflammatory insult.
  • Requiring positive pressure ventilation via an endo-tracheal tube.
  • Impaired oxygenation - arterial partial pressure of oxygen to inspire fraction of oxygen ratio (P/F) <300 mmHg.
  • At least one quadrant of pulmonary infiltrate present on CXR.
  • Enrolled within 24 hrs of developing all of these criteria.

Exclusion Criteria19

  • Known hypersensitivity to alteplase (t-PA)
  • Aspirin in the last week
  • Any therapeutic anti-coagulant therapy
  • Significant bleeding disorder within the past six months
  • Any history of brain or spinal injury including trauma, stroke, transient ischaemic attack, neoplasm, surgery, infection, aneurysm or intracranial bleed.
  • Uncontrolled hypertension, systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg.
  • Recent (within ten days) prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes), obstetric delivery, organ biopsy, puncture of non-compressible blood vessel (e.g. subclavian vein), major surgery or significant trauma.
  • Documented ulcerative gastrointestinal disease during the last three months.
  • Arterial aneurysms, arterial/venous malformations.
  • Neoplasm with increased bleeding risk.
  • Bacterial endocarditis, pericarditis.
  • Acute pancreatitis.
  • Severe hepatic disease/ dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) or active hepatitis.
  • Age <18 or > 75
  • Pulmonary haemorrhage in previous 12 months
  • Major surgery planned over the next 2 days
  • Diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions.
  • Unlikely to survive 24 hours
  • Platelet count below 80,000/mm3

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Interventions

Administration of tissue plasminogen activator (t-PA) on one occasion. Dose escalation study The first 4 patients will receive 1. 10 mg bolus and 10 mg over 30 min. The second 4 patients

Administration of tissue plasminogen activator (t-PA) on one occasion. Dose escalation study The first 4 patients will receive 1. 10 mg bolus and 10 mg over 30 min. The second 4 patients will receive 2. 10 mg bolus and 20 mg over 30 min. The final 4 patients will receive 3. 10 mg bolus and 40 mg over 30 min.

Locations(1)

Australia

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ACTRN12610000950066