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

This study is currently recruiting participants.
Verified March 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Thomas Bech Jorgensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01291290
First received: February 7, 2011
Last updated: March 13, 2013
Last verified: March 2013
History of Changes

February 7, 2011
March 13, 2013
March 2010
March 2014   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Mortality during the first 30days after randomization, and time to death during the 30 days.
Same as current
Complete list of historical versions of study NCT01291290 on ClinicalTrials.gov Archive Site
  • Acute myocardial infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The need for dialysis during the first 30 days, time to start of dialysis and length.
  • Post operative pulmonary insufficiency [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Length of respirator treatment in the ICU during the first 30 days.
  • Length of stay in ICU [ Time Frame: until discharged from ICU ] [ Designated as safety issue: No ]
    Length of stay in ICU
  • Length of stay in hospital [ Time Frame: until discharged from hospital ] [ Designated as safety issue: No ]
    Until discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ruptured Abdominal Aortic Aneurism
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
  • No Intervention: Control treatment
    Usual transfusion regime to patients with rAAA
  • Experimental: Thrombocyte
    Early thrombocyte administration to patients with rAAA
    Intervention: Procedure: Platelet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
March 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Thomas Bech Jørgensen, MD 25620901 starttrial@gmail.com
Denmark
 
NCT01291290
H-D-2009-002
No
Thomas Bech Jorgensen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Study Chair: Henning Bay Nielsen, MD
Rigshospitalet, Denmark
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP