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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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291290

Contacts
Contact: Thomas Bech Jørgensen, MD 25620901 starttrial@gmail.com

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Oesterbro, Denmark, 2100
Contact: Thomas Bech Jørgensen, MD     25620901     starttrial@gmail.com    
Principal Investigator: Thomas Bech Jørgensen, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Henning Bay Nielsen, MD
  More Information

Additional Information:
Trial homepage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Thomas Bech Jorgensen, Afdelingslaege, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01291290     History of Changes
Other Study ID Numbers: H-D-2009-002
Study First Received: February 7, 2011
Last Updated: March 13, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
rAAA
Platelets
TEG
Massive bleeding
Coagulopathy

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Rupture
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013