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Plasma exchange for lung haemorrhages in leptospirosis

Effect of therapeutic plasma exchange on pulmonary haemorrhagic syndrome due to leptospirosis; an open-labeled randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2018/013
Enrollment
Unknown
Registered
2018-05-09
Start date
2018-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Leptospirosis

Interventions

- Study setting: Medical wards, emergency care unit and intensive care units of the Teaching Hospital, Karapitiya - Randomisation: patients will be allocated to two arms using the Block randomiz

Sponsors

Dr Nalaka Herath
Lead Sponsor
Dr Wimalasiri Uluwatta
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: - Age 15 to 80 , with lung hemorrhages due to leptospirosis. Diagnosis of leptospirosis: Patients with a clinical picture suggestive of leptospirosis and confirmed with PCR, MAT or both) Definition of leptospirosis associated pulmonary hemorrhage: Patient with confirmed leptospirosis presenting with haemoptysis, arterial hypoxemia (Acute Lung Score 10% from the previous value), or diffused alveolar shadows in the chest radiograph. The above manifestations should not have an alternative explanation.

Exclusion criteria

Exclusion criteria: - Chronic kidney disease Stages iii, iv, v - Chronic hepatitis and liver cirrhosis of any etiology (compensated or decompensated) - Clinically manifested chronic obstructive airway disease, bronchial asthma, lung fibrosis - Pregnant women - Patients aged 80 years - Patients who are haemodynamically unstable for TPE will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Overall survival [During the hospital stay and at the time of discharge from the hospital ]

Secondary

MeasureTime frame
Duration of the ICU stay and hospital stay [During the hospital stay and at the time of discharge from the hospital ] Need of ventilatory support [ During the hospital stay and at the time of discharge from the hospital ] Need of inotrophs to support blood pressure [ During the hospital stay and at the time of discharge from the hospital ] Use of antiarrhythmic agents [ During the hospital stay and at the time of discharge from the hospital ] Use of renal replacement therapy [ During the hospital stay and at the time of discharge from the hospital ] Use of liver failure therapy [ During the hospital stay and at the time of discharge from the hospital ] Incidence of sepsis [ During the hospital stay and at the time of discharge from the hospital ] Incidence of pneumonia [ During the hospital stay and at the time of discharge from the hospital ] Incidence of line infection spontaneous bleeding [ During the hospital stay and at the time of discharge from the hospital ]

Countries

Sri Lanka

Contacts

Public ContactProf Sarath Lekamwasam

Professor of Medicine

slekamwasam@gmail.com091234730

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026