Back to resultsSTART - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism (rAAA)
Primary Purpose
Ruptured Abdominal Aortic Aneurism
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Platelet
Sponsored by
About this trial
This is an interventional treatment trial for Ruptured Abdominal Aortic Aneurism focused on measuring rAAA, Platelets, TEG, Massive bleeding, Coagulopathy
Eligibility 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
Sites / Locations
- RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control treatment
Thrombocyte
Arm Description
Usual transfusion regime to patients with rAAA
Early thrombocyte administration to patients with rAAA
Outcomes
Primary Outcome Measures
Mortality
Mortality during the first 30days after randomization, and time to death during the 30 days.
Secondary Outcome Measures
Acute myocardial infarction
Development of AMI during the first 30 days after randomization, and the time to development during the first 30 days.
Post operative kidney failure
The need for dialysis during the first 30 days, time to start of dialysis and length.
Post operative pulmonary insufficiency
Length of respirator treatment in the ICU during the first 30 days.
Length of stay in ICU
Length of stay in ICU
Length of stay in hospital
Until discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.
Full Information
NCT ID
NCT01291290
First Posted
February 7, 2011
Last Updated
March 13, 2013
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01291290
Brief Title
START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism
Acronym
rAAA
Official Title
Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ruptured Abdominal Aortic Aneurism
Keywords
rAAA, Platelets, TEG, Massive bleeding, Coagulopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control treatment
Arm Type
No Intervention
Arm Description
Usual transfusion regime to patients with rAAA
Arm Title
Thrombocyte
Arm Type
Experimental
Arm Description
Early thrombocyte administration to patients with rAAA
Intervention Type
Procedure
Intervention Name(s)
Platelet
Other Intervention Name(s)
Thrombocyte, Platelets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality during the first 30days after randomization, and time to death during the 30 days.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Acute myocardial infarction
Description
Development of AMI during the first 30 days after randomization, and the time to development during the first 30 days.
Time Frame
30 days
Title
Post operative kidney failure
Description
The need for dialysis during the first 30 days, time to start of dialysis and length.
Time Frame
30 days
Title
Post operative pulmonary insufficiency
Description
Length of respirator treatment in the ICU during the first 30 days.
Time Frame
30 days
Title
Length of stay in ICU
Description
Length of stay in ICU
Time Frame
until discharged from ICU
Title
Length of stay in hospital
Description
Until discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.
Time Frame
until discharged from hospital
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Bech Jørgensen, MD
Phone
25620901
Email
starttrial@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Bay Nielsen, MD
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Oesterbro
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Bech Jørgensen, MD
Phone
25620901
Email
starttrial@gmail.com
First Name & Middle Initial & Last Name & Degree
Thomas Bech Jørgensen, MD
12. IPD Sharing Statement
Learn more about this trial
START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism
We'll reach out to this number within 24 hrs