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

NCT ID: NCT01291290

Last Updated: 2013-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ruptured Abdominal Aortic Aneurism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control treatment

Usual transfusion regime to patients with rAAA

Group Type NO_INTERVENTION

No interventions assigned to this group

Thrombocyte

Early thrombocyte administration to patients with rAAA

Group Type EXPERIMENTAL

Platelet

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Thrombocyte Platelets

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Thomas Bech Jorgensen

Afdelingslaege

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henning Bay Nielsen, MD

Role: STUDY_CHAIR

Locations

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Rigshospitalet

Copenhagen, Oesterbro, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Thomas Bech Jørgensen, MD

Role: CONTACT

Facility Contacts

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Thomas Bech Jørgensen, MD

Role: primary

Other Identifiers

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H-D-2009-002

Identifier Type: -

Identifier Source: org_study_id

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