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Status unknownNCT01291290rAAAUpdated Mar 14, 2013

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

An interventional study of Platelet in Ruptured Abdominal Aortic Aneurism, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2013-03-14.

Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Ruptured Abdominal Aortic Aneurism

Keywords

  • rAAA
  • Platelets
  • TEG
  • Massive bleeding
  • Coagulopathy
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 420 is above the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • formerly randomized in the study
  • aneurism not ruptured during operation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
420 participants (estimated)

Study arms

  • No intervention
    Control treatment

    Usual transfusion regime to patients with rAAA

  • Experimental
    Thrombocyte

    Early thrombocyte administration to patients with rAAA

    Procedure: Platelet

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.

    Also known as: Thrombocyte, Platelets

06

What researchers measure

Primary outcomes

  1. Mortality

    Mortality during the first 30days after randomization, and time to death during the 30 days.

    Time frame: 30 days

Secondary outcomes

  1. Acute myocardial infarction

    Development of AMI during the first 30 days after randomization, and the time to development during the first 30 days.

    Time frame: 30 days

  2. Post operative kidney failure

    The need for dialysis during the first 30 days, time to start of dialysis and length.

    Time frame: 30 days

  3. Post operative pulmonary insufficiency

    Length of respirator treatment in the ICU during the first 30 days.

    Time frame: 30 days

  4. Length of stay in ICU

    Length of stay in ICU

    Time frame: until discharged from ICU

  5. Length of stay in hospital

    Until discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.

    Time frame: until discharged from hospital

07

Study locations

1 of 1 sites recruiting
  • Rigshospitalet
    Copenhagen, Oesterbro 2100, Denmark
    • Thomas Bech Jørgensen, MD · Contact · starttrial@gmail.com · 25620901
    • Thomas Bech Jørgensen, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01291290
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Thomas Bech Jorgensen (Afdelingslaege, Rigshospitalet, Denmark) — Principal investigator
First posted
Feb 8, 2011
Start date
Mar 2010
Primary completion
Mar 2014 (estimated)
Completion
Mar 2015 (estimated)
Last update
Mar 14, 2013

Study contacts

Thomas Bech Jørgensen, MD
Contact
starttrial@gmail.com
25620901
Henning Bay Nielsen, MD
study chair

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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