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

March 13, 2013 updated by: Thomas Bech Jorgensen, Rigshospitalet, Denmark

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Oesterbro
      • Copenhagen, Oesterbro, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Thomas Bech Jørgensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • Platelets
  • Thrombocyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Mortality during the first 30days after randomization, and time to death during the 30 days.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
30 days
Post operative pulmonary insufficiency
Time Frame: 30 days
Length of respirator treatment in the ICU during the first 30 days.
30 days
Length of stay in ICU
Time Frame: until discharged from ICU
Length of stay in ICU
until discharged from 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.
until discharged from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Henning Bay Nielsen, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2009-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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