START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism (rAAA)
This study is currently recruiting participants.
Verified March 2013 by Rigshospitalet, Denmark
Information provided by (Responsible Party):
Thomas Bech Jorgensen, Rigshospitalet, Denmark
First received: February 7, 2011
Last updated: March 13, 2013
Last verified: March 2013
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 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.
|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)|
No Intervention: Control treatment
Usual transfusion regime to patients with rAAA
Early thrombocyte administration to patients with rAAA
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291290
|Contact: Thomas Bech Jørgensen, MDfirstname.lastname@example.org|
|Copenhagen, Oesterbro, Denmark, 2100|
|Contact: Thomas Bech Jørgensen, MD 25620901 email@example.com|
|Principal Investigator: Thomas Bech Jørgensen, MD|
Sponsors and Collaborators
|Study Chair:||Henning Bay Nielsen, MD|