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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02906878
Other study ID # 2015-AO1924-45
Secondary ID
Status Recruiting
Phase N/A
First received July 5, 2016
Last updated September 19, 2016
Start date June 2016
Est. completion date July 2017

Study information

Verified date September 2016
Source University Hospital, Angers
Contact Nicolas LEROLLE, MD PhD
Phone +33241353478
Email NiLerolle@chu-angers.fr
Is FDA regulated No
Health authority FRANCE : ANSM
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

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

Locations

Country Name City State
France University Hospital Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Transfusion Safety - assessed by Troubles during process Troubles during process (pneumothorax, laying failure, hematoma) Hematoma at H+24:00 Immunisation anti HLA,HPA One day after transfusion No
Secondary Transfusion Efficacy Number of blood or platelets transfusion One month after transfusion No
Secondary Description of patients treatment Type of received chemotherapy One week before and one month after transfusion No
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