CHU de Nantes
Nantes, 44093, France
NCT Number: NCT03515447
The investigators developed a platelet transfusion saving strategy based on thrombopoietin administration in heart or lung transplantation (HLT) patients or assist device implantation in bridge-to-transplantation (BTT) or bridge to-decision (BTD). This strategy was applied from May 2014 to October 2015 in patients whose platelet counts were below 100 Giga per liter (G/L). As part of a health care quality improvement project, the investigators evaluated this strategy in a before/after design. January 2010 to December 2013 constituted the before period.
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Notify Me18 year–65 year
All sexes
Observational
Nantes, 44093, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Until day 28
Cumulative platelets concentrate from day 1 to day 28 after thoracic transplantation or assist device implantation.
Time frame: Until day 28
The data will be collected from the blood service data base.
Time frame: Until day 28
The data will be collected from the blood service data base.
Time frame: Until day 28
The data will be collected from the blood service data base.
Time frame: Until 1 year
Time frame: At day 15, day30, month3, month6 and one 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.
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.
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.
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.
Time frame: At day 28 and day 90
Nantes University Hospital
Other
Romiplostim as a Platelet-transfusion Saving Strategy After Thoracic Transplantation and Circulatory or Respiratory Assistance Devices: A Before-after Study of 172 Patients
Acronym: N-PLATE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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