Platelet Kinetics After Platelet Transfusion for the Placement of a Central Venous Catheter (PLATCAT)

September 19, 2016 updated by: University Hospital, Angers

Evaluation of the Effectiveness and Security of the Prophylactic Platelet Transfusion in Thrombocytopenic Patients Requiring the Placement of a Central Venous Catheter

PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Haematology patients who needs a central venous catheter and with a non-auto immune thrombopenia

Description

Inclusion Criteria:

  • Admission en haematology unit
  • Need for a central venous catheter
  • Thrombopenia < 50 G/L

Exclusion Criteria:

  • Patient protected by law
  • Pregnant or breastfeeding women
  • Peripheral thrombopenia
  • Patient admitted in Intensive Care Unit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
72 hours thrombocythemia kinetics after a platelet transfusion
Time Frame: 72 hours post transfusion
Blood drawing a H-1:00, H+0:10, H+1:00, H+4:00, H+24h00, H+72:00 Evaluation of platelets count on sodium citrate tube.
72 hours post transfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion Safety - assessed by Troubles during process
Time Frame: One day after transfusion
Troubles during process (pneumothorax, laying failure, hematoma) Hematoma at H+24:00 Immunisation anti HLA,HPA
One day after transfusion
Transfusion Efficacy
Time Frame: One month after transfusion
Number of blood or platelets transfusion
One month after transfusion
Description of patients treatment
Time Frame: One week before and one month after transfusion
Type of received chemotherapy
One week before and one month after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Nicolas LEROLLE, MD PhD, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (ESTIMATE)

September 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-AO1924-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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