Romiplostim in Thoracic Transplantation (N-PLATE)
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|ClinicalTrials.gov Identifier: NCT03515447|
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment|
|Thrombocytopenia||Other: Non interventional study|
In may 2014, after Heart or Lung transplantation or assist device implantation, the investigators decided to off-label administered Romiplostim in patients with thrombocytopenia below 100 Giga per liter. The purpose was to reduce platelets transfusion side effects. Romiplostim was used off treatment algorithm was based on previously published data in idiopathic, thrombocytopenia, cirrhotic and hematological patients. The first subcutaneous injection of 1.5 to 2 μg/kg of romiplostim was administered in the postoperative periods. An algorithm based on patient weight and platelet count evolution was established to determine romiplostim doses to administered weekly. Romiplostim posology was adjusted between 2 and 5μg/kg according to platelet count with a maximum of 4 administrations in the ICU. If platelets remained below 50 Giga per liter after 2 injections, bone marrow analysis after hematologist referral was discussed. Platelet count until day 15 after the last injection was monitored to detect thrombocytosis.
In January 2016, the investigators decided to retrospectively assess Romiplostim implementation in the standard of care in the ICU through a Healthcare quality improvement project in a before/after design.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Romiplostim as a Platelet-transfusion Saving Strategy After Thoracic Transplantation and Circulatory or Respiratory Assistance Devices: A Before-after Study of 172 Patients|
|Actual Study Start Date :||May 1, 2014|
|Actual Primary Completion Date :||October 31, 2015|
|Actual Study Completion Date :||October 31, 2015|
During this period no patient received Romiplostim.
Application of the transfusion saving strategy protocol through Romiplostim treatment.
The first subcutaneous injection of 1.5 to 2 µg/kg of romiplostim was administered in the post-operative periods. An algorithm based on patient weight and platelet count was established to determine romiplostim doses. One injection per week was performed. Romiplostim posology was adjusted between 2 and 5µg/kg every week according to platelet count with a maximum of 4 administrations in the ICU.
Other: Non interventional study
- Number of platelets concentrate [ Time Frame: Until day 28 ]Cumulative platelets concentrate from day 1 to day 28 after thoracic transplantation or assist device implantation.
- Number of unit of Fresh Frozen Plasma transfused until day 28. [ Time Frame: Until day 28 ]The data will be collected from the blood service data base.
- Number of unit of Packed red blood cells transfused until day 28. [ Time Frame: Until day 28 ]The data will be collected from the blood service data base.
- Number of unit of whole labile blood products until day 28. [ Time Frame: Until day 28 ]The data will be collected from the blood service data base.
- Transfusion cost [ Time Frame: Until 1 year ]
- alloimmunisation (DSA or non-DSA) until 1 year [ Time Frame: At day 15, day30, month3, month6 and one year ]
- Worst grade of graft rejection until 1 year. [ Time Frame: At day 15, day30, month3, month6 and one year ]Acute cellular rejection (ACR) and antibody mediated rejection (AMR) will be quoted. We will considered the worst rejection grade.
- Thrombotic event in ICU (stroke, deep venous thrombosis and pulmonary embolism) [ Time Frame: Thrombotic events will be assessed daily in ICU until ICU discharge, up to 28 days. Pulmonary embolism and stroke will be diagnosed by CT scan and deep venous thrombosis by Echo-doppler examination. ]
- Length of stay in ICU [ Time Frame: From ICU admission to ICU discharge, up to 90 days. If the patient dies in ICU, the length of stay in ICU will be calculated from ICU admission until death. ]
- Mechanical ventilation duration [ Time Frame: Will be assessed daily from admission to ICU discharge, up to 28 days.Mechanical ventilation stand for invasive ventilator support such as endotracheal intubation or tracheostomy.Each day began with invasive ventilator support will be recorded. ]
- Mortality in ICU [ Time Frame: At day 28 and day 90 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515447
|Principal Investigator:||Karim ASEHNOUNE, MD, PhD||CHU de Nantes|