NCT02906878

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

July 5, 2016

Last Update Submit

September 19, 2016

Conditions

ThrombopeniaCentral Venous Catheter Placement

Keywords

Intensive CareHaematologyPlatelets prophylactic transfusion

Outcome Measures

Primary Outcomes (1)

  • 72 hours thrombocythemia kinetics after a platelet 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 Outcomes (3)

  • Transfusion Safety - assessed by Troubles during process

    One day after transfusion

  • Transfusion Efficacy

    One month after transfusion

  • Description of patients treatment

    One week before and one month after transfusion

Interventions

Platelets transfusionPROCEDURE

Prophylactic platelet transfusion in thrombocytopenic patients for the placement of a central venous catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Nicolas LEROLLE, MD PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas LEROLLE, MD PhD

CONTACT

+33241353478NiLerolle@chu-angers.fr

Aline SCHMIDT, MD

CONTACT

alschmidt@chu-angers.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

September 20, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)