START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism (rAAA)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|