Romiplostim in Thoracic Transplantation

Completed

• Conditions: Thrombocytopenia
• Interventions: Other: Non interventional study

• Registration Number: NCT03515447
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2015-10-31
• Study Completion: 2015-10-31
• Study First Submitted: 2018-03-21
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-02
• Last Update Submitted: 2018-05-02
• Study First Posted: 2018-05-03
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients admitted in ICU after HLT, BTT or BTD assist device implantation with platelet counts below 100G/L at least once in the post-operative period

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Exclusion Criteria

• age under 18 or over 65, combined heart and lung transplantation, multiple organ dysfunction syndrome (MODS), pericardial effusion, active surgical bleeding, assist device dysfunction or suspected/diagnosed heparin-induced thrombocytopenia. We also excluded patients with myelodysplastic or myeloproliferative syndrome, hematological malignancy, severe liver cirrhosis with a Child-Pugh score superior to 6, receiving antiplatelet therapy, aplasia diagnosed on bone marrow analyses, pregnancy, thrombophilia, prior pulmonary embolism or stroke in the previous 6 months. Thrombophilia was defined as factor V Leyden mutation, activated protein C resistance, protein S deficiency, protein C deficiency, prothrombin gene mutation, factor VIII excess, ATIII deficiency or antiphospholipid syndrome. For the assistance population, the protocol also excluded destination-therapy devices or patients with transplantation contraindications

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
After period	Non interventional study	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.

Primary Outcome Measures

Name	Time	Method
Number of platelets concentrate	Until day 28	Cumulative platelets concentrate from day 1 to day 28 after thoracic transplantation or assist device implantation.

Secondary Outcome Measures

Name	Time	Method
Number of unit of Packed red blood cells transfused until day 28.	Until day 28	The data will be collected from the blood service data base.
Transfusion cost	Until 1 year
alloimmunisation (DSA or non-DSA) until 1 year	At day 15, day30, month3, month6 and one year
Thrombotic event in ICU (stroke, deep venous thrombosis and pulmonary embolism)	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.
Number of unit of Fresh Frozen Plasma transfused until day 28.	Until day 28	The data will be collected from the blood service data base.
Worst grade of graft rejection until 1 year.	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.
Length of stay in ICU	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.
Mortality in ICU	At day 28 and day 90
Number of unit of whole labile blood products until day 28.	Until day 28	The data will be collected from the blood service data base.
Mechanical ventilation duration	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.