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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01291290
Recruitment Status : Unknown
Verified March 2013 by Thomas Bech Jorgensen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : February 8, 2011
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):
Thomas Bech Jorgensen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Ruptured Abdominal Aortic Aneurism Procedure: Platelet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
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
Study Start Date : March 2010
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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.

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

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

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

  5. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Thomas Bech Jorgensen, Afdelingslaege, Rigshospitalet, Denmark Identifier: NCT01291290     History of Changes
Other Study ID Numbers: H-D-2009-002
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 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