NCT00151866

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of transfusions with platelets stored in platelet additive solution II compared to plasma storage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

February 27, 2007

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

February 26, 2007

Conditions

Hemato-Oncologic PatientsMyelosuppressionThrombocytopenia

Keywords

ThrombopeniaPlatelet transfusionIncrementTransfusion reactionsBleeding complication

Outcome Measures

Primary Outcomes (1)

  • Corrected count increment

Secondary Outcomes (1)

  • Bleeding complications

Interventions

platelet transfusionPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical centre

Leiden, Netherlands

Location

MeSH Terms

Conditions

ThrombocytopeniaTransfusion Reaction

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • J.L.H. Kerkhoffs, MD

    Sanquin rbbd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

October 1, 2003

Study Completion

May 1, 2005

Last Updated

February 27, 2007

Record last verified: 2005-09

Locations

NL(1)