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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Thomas Bech Jorgensen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Thomas Bech Jorgensen, Rigshospitalet, Denmark Identifier:
First received: February 7, 2011
Last updated: March 13, 2013
Last verified: March 2013
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.

Condition Intervention
Ruptured Abdominal Aortic Aneurism Procedure: Platelet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department

Resource links provided by NLM:

Further study details as provided by Thomas Bech Jorgensen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ]
    Mortality during the first 30days after randomization, and time to death during the 30 days.

Secondary Outcome Measures:
  • Acute myocardial infarction [ Time Frame: 30 days ]
    Development of AMI during the first 30 days after randomization, and the time to development during the first 30 days.

  • Post operative kidney failure [ Time Frame: 30 days ]
    The need for dialysis during the first 30 days, time to start of dialysis and length.

  • Post operative pulmonary insufficiency [ Time Frame: 30 days ]
    Length of respirator treatment in the ICU during the first 30 days.

  • Length of stay in ICU [ Time Frame: until discharged from ICU ]
    Length of stay in ICU

  • Length of stay in hospital [ Time Frame: until discharged from hospital ]
    Until discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.

Estimated Enrollment: 420
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control treatment
Usual transfusion regime to patients with rAAA
Experimental: Thrombocyte
Early thrombocyte administration to patients with rAAA
Procedure: Platelet
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.
Other Names:
  • Thrombocyte
  • Platelets


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01291290

Contact: Thomas Bech Jørgensen, MD 25620901

Rigshospitalet Recruiting
Copenhagen, Oesterbro, Denmark, 2100
Contact: Thomas Bech Jørgensen, MD    25620901   
Principal Investigator: Thomas Bech Jørgensen, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Study Chair: Henning Bay Nielsen, MD
  More Information

Additional Information:
Responsible Party: Thomas Bech Jorgensen, Afdelingslaege, Rigshospitalet, Denmark Identifier: NCT01291290     History of Changes
Other Study ID Numbers: H-D-2009-002
Study First Received: February 7, 2011
Last Updated: March 13, 2013

Keywords provided by Thomas Bech Jorgensen, Rigshospitalet, Denmark:
Massive bleeding

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Rupture
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries
Aneurysm, Ruptured processed this record on September 21, 2017