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

Ruptured Abdominal Aortic Aneurism Clinical Trial

— rAAA  

Official title:

Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01291290
• Other study ID #: H-D-2009-002
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2011
• Last updated: March 13, 2013
• Start date: March 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2013
• Source: Rigshospitalet, Denmark
• Contact: Thomas Bech Jørgensen, MD
• Phone: 25620901
• Email: starttrial[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Rupture
• Rupture
• Ruptured Abdominal Aortic Aneurism

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Oesterbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality during the first 30days after randomization, and time to death during the 30 days.	30 days	No
Secondary	Acute myocardial infarction	Development of AMI during the first 30 days after randomization, and the time to development during the first 30 days.	30 days	No
Secondary	Post operative kidney failure	The need for dialysis during the first 30 days, time to start of dialysis and length.	30 days	No
Secondary	Post operative pulmonary insufficiency	Length of respirator treatment in the ICU during the first 30 days.	30 days	No
Secondary	Length of stay in ICU	Length of stay in ICU	until discharged from ICU	No
Secondary	Length of stay in hospital	Until discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.	until discharged from hospital	No

External Links

•   Trial homepage