Rotational Thromboelastometry Activated Transfusion In Trauma Trial

NCT ID: NCT03765866

Last Updated: 2020-05-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-17

Brief Summary

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This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.

Detailed Description

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This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.

Conditions

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Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Massive Transfusion Protocol Guided

Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP)

Group Type NO_INTERVENTION

No interventions assigned to this group

Thromboelastometry guided transfusion

Clinicians will transfuse patients according to ROTEM results.

Group Type EXPERIMENTAL

Thromboelastometry guided transfusion

Intervention Type PROCEDURE

Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP

Interventions

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Thromboelastometry guided transfusion

Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Trauma patient
2. MTP Activation
3. Only patients ≥ 14 years old
4. Alive at 31 mins after arrival in ED

Exclusion Criteria

1. Transfer from OSH
2. Received CPR for more than 5 mins
3. Burned
4. Pregnant or Prisoner
5. Known DNR
6. Jehovah's witness
Minimum Eligible Age

14 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael W. Cripps, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.

Reference Type BACKGROUND
PMID: 24103457 (View on PubMed)

Other Identifiers

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022015-093

Identifier Type: -

Identifier Source: org_study_id

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