START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism
rAAA
Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department
1 other identifier
interventional
420
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of platelet infusion prior to transfer to a vascular surgical department in patients with a ruptured abdominal aortic aneurism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 14, 2013
March 1, 2013
4 years
February 7, 2011
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Mortality during the first 30days after randomization, and time to death during the 30 days.
30 days
Secondary Outcomes (5)
Acute myocardial infarction
30 days
Post operative kidney failure
30 days
Post operative pulmonary insufficiency
30 days
Length of stay in ICU
until discharged from ICU
Length of stay in hospital
until discharged from hospital
Study Arms (2)
Control treatment
NO INTERVENTIONUsual transfusion regime to patients with rAAA
Thrombocyte
EXPERIMENTALEarly thrombocyte administration to patients with rAAA
Interventions
2 portions of platelets (one portion = pooled from 4 donors, 350ml) infused when diagnosed with rAAA and vascular surgeon accepts to receive the patient, infused before transportation.
Eligibility Criteria
You may qualify if:
- diagnosed with rAAA either by clinical evaluation or CT or UL
You may not qualify if:
- formerly randomized in the study
- aneurism not ruptured during operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, Oesterbro, 2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Henning Bay Nielsen, MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Afdelingslaege
Study Record Dates
First Submitted
February 7, 2011
First Posted
February 8, 2011
Study Start
March 1, 2010
Primary Completion
March 1, 2014
Study Completion
March 1, 2015
Last Updated
March 14, 2013
Record last verified: 2013-03