Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation (NCT00224406) | Clinical Trial Compass
CompletedPhase 2
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
United States114 participantsStarted 2005-05-01
Plain-language summary
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 \[formerly interleukin (IL)-8\]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved functional and clinical outcomes in lung transplantation patients.
The safety of repertaxin in the specific clinical setting was also evaluated.
The ability of repertaxin to reduce target cells (polymorphonuclear leukocyte \[PMN\]) infiltration into the graft was evaluated to confirm its mechanism of action.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients accepted and listed for transplantation due to irreversible, progressive disabling, end-stage pulmonary disease;
* Ages 18 to 65 years;
* Body weight 30 to 95 kg (inclusive) (i.e. up to 95.99 kg);
* Planned isolated (single and bi-lateral) lung transplant from a non-living donor with brain death. This included lobar lung transplant involving excision and sizing of a cadaver donor lobe to meet the thoracic dimension of the recipient before being transplanted;
* Normal renal function at the time of transplant as per calculated creatinine clearance (Clcr) 60 mL/min. Creatinine clearance was calculated according to the Cockcroft-Gault formula;
* Patient was willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations;
* Patient gave written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent could be withdrawn by the patient at any time without prejudice to their future medical care.
Exclusion Criteria:
* Recipients of an intended multiple organ transplant, including heart-lung and liver-lung transplantation;
* Recipients of a lung from a living lobar donor;
* Recipients of a lung from a non-heart beating donor;
* Re-do lung transplantation;
* Recipients requiring mechanical ventilation at the time of transplant;
* Recipients with an extra-respiratory tract site of infection (positive blood cultur…
What they're measuring
1
PaO2/FiO2 Ratio at ICU Admission (Time 0) and 24 Hours
Timeframe: At T0 (time of ICU admission) and 24 hours post-ICU admission