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START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism

Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01291290
Acronym
rAAA
Enrollment
420
Registered
2011-02-08
Start date
2010-03-31
Completion date
2015-03-31
Last updated
2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ruptured Abdominal Aortic Aneurism

Keywords

rAAA, Platelets, TEG, Massive bleeding, Coagulopathy

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.

Interventions

PROCEDUREPlatelet

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.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* diagnosed with rAAA either by clinical evaluation or CT or UL

Exclusion criteria

* formerly randomized in the study * aneurism not ruptured during operation

Design outcomes

Primary

MeasureTime frameDescription
Mortality30 daysMortality during the first 30days after randomization, and time to death during the 30 days.

Secondary

MeasureTime frameDescription
Acute myocardial infarction30 daysDevelopment of AMI during the first 30 days after randomization, and the time to development during the first 30 days.
Post operative kidney failure30 daysThe need for dialysis during the first 30 days, time to start of dialysis and length.
Post operative pulmonary insufficiency30 daysLength of respirator treatment in the ICU during the first 30 days.
Length of stay in ICUuntil discharged from ICULength of stay in ICU
Length of stay in hospitaluntil discharged from hospitalUntil discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.

Countries

Denmark

Contacts

Primary ContactThomas Bech Jørgensen, MD
starttrial@gmail.com25620901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026