START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism (rAAA)
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Ruptured Abdominal Aortic Aneurism||Procedure: Platelet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- Mortality [ Time Frame: 30 days ]Mortality during the first 30days after randomization, and time to death during the 30 days.
- 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.
- Post operative kidney failure [ Time Frame: 30 days ]The need for dialysis during the first 30 days, time to start of dialysis and length.
- Post operative pulmonary insufficiency [ Time Frame: 30 days ]Length of respirator treatment in the ICU during the first 30 days.
- Length of stay in ICU [ Time Frame: until discharged from ICU ]Length of stay in 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Study Chair:||Henning Bay Nielsen, MD|