Ruptured Abdominal Aortic AneurismrAAANCT01291290
START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism
A study testing Platelet in people with Ruptured Abdominal Aortic Aneurism, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ruptured Abdominal Aortic Aneurism
- What is being tested?
- Platelet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with rAAA either by clinical evaluation or CT or UL
Who cannot join
- formerly randomized in the study
- aneurism not ruptured during operation
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Oesterbro, 2100
Thomas Bech Jørgensen, MD, 25620901, starttrial@gmail.com
Thomas Bech Jørgensen, MD
About this study
Official title: Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department
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.
- Conditions
- Ruptured Abdominal Aortic Aneurism
- Being tested
- Platelet
- Keywords
- rAAA, Platelets, TEG, Massive bleeding, Coagulopathy
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlateletProcedure or surgery
Also called Thrombocyte, Platelets
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.
| Study group | Role | What they receive |
|---|---|---|
| Control treatment | No intervention | Usual transfusion regime to patients with rAAA |
| Thrombocyte | Experimental | Early thrombocyte administration to patients with rAAA Receives: Procedure: Platelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality during the first 30days after randomization, and time to death during the 30 days.
Measured: 30 days
Secondary outcomes (5)
Acute myocardial infarction
Development of AMI during the first 30 days after randomization, and the time to development during the first 30 days.
Measured: 30 days
Post operative kidney failure
The need for dialysis during the first 30 days, time to start of dialysis and length.
Measured: 30 days
Post operative pulmonary insufficiency
Length of respirator treatment in the ICU during the first 30 days.
Measured: 30 days
Length of stay in ICU
Length of stay in ICU
Measured: until discharged from ICU
Length of stay in hospital
Until discharged from main surgical department or if transferred to local hospital, when the patient leave local hospital.
Measured: until discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Abdominal Aortic AneurismStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Bech Jorgensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henning Bay Nielsen, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291290
- Sponsor's protocol ID
- H-D-2009-002
- Acronym
- rAAA
- Status last verified
- Mar 2013
- First submitted
- 7 Feb 2011
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department
- ClinicalTrials.gov ID
- NCT01291290
- Acronym / sponsor ID
- rAAA / H-D-2009-002
- Conditions
- Ruptured Abdominal Aortic Aneurism
- Keywords
- rAAA, Platelets, TEG, Massive bleeding, Coagulopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control treatment | No intervention | –Usual transfusion regime to patients with rAAA |
| Thrombocyte | Experimental | Procedure: PlateletEarly thrombocyte administration to patients with rAAA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with rAAA either by clinical evaluation or CT or UL
Key exclusion criteria (2 listed)
- formerly randomized in the study
- aneurism not ruptured during operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlateletAlso: Thrombocyte, Platelets2 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. | Procedure or surgery | Thrombocyte |
Primary outcome
Mortality
Time frame: 30 days
Mortality during the first 30days after randomization, and time to death during the 30 days.
5 secondary outcomes
Acute myocardial infarction
Time frame: 30 days
Post operative kidney failure
Time frame: 30 days
Post operative pulmonary insufficiency
Time frame: 30 days
Length of stay in ICU
Time frame: until discharged from ICU
Length of stay in hospital
Time frame: until discharged from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Bay Nielsen, MD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet in people with Ruptured Abdominal Aortic Aneurism, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Bech Jørgensen, MD (25620901, starttrial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.