Romiplostim in Thoracic Transplantation

NCT03515447 | Completed

• 1 other identifier: RC17_0044
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopenia

Keywords

transfusion saving strategy; heart or lung transplantation; assist device; Extra Corporal Life Support (ECLS); Left Ventricular Assist Device (LVAD ); Total artificial Heart

Outcome Measures

Primary Outcomes (1)

• Number of platelets concentrate

  Cumulative platelets concentrate from day 1 to day 28 after thoracic transplantation or assist device implantation.

  Until day 28

Secondary Outcomes (10)

• Number of unit of Fresh Frozen Plasma transfused until day 28.

  Until day 28

• Number of unit of Packed red blood cells transfused until day 28.

  Until day 28

• Number of unit of whole labile blood products until day 28.

  Until day 28

• Transfusion cost

  Until 1 year

• alloimmunisation (DSA or non-DSA) until 1 year

  At day 15, day30, month3, month6 and one year

Study Arms (2)

Before period

During this period no patient received Romiplostim.

After period

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

Interventions

Non interventional study OTHER

After period

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart or lung transplantation (HLT) patients or assist device implantation in bridge-to-transplantation or to-decision; with platelet counts below 100G/L at least once in the post-operative period

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Karim ASEHNOUNE, MD, PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: May 3, 2018
• Study Start: May 1, 2014
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: June 24, 2026

Record last verified: 2018-05

Locations

FR (1)