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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Aortic Rupture
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries
Aneurysm, Ruptured

ClinicalTrials.gov processed this record on September 30, 2014