NCT00459160

Brief Summary

The goal of this study will be to determine if a lower than normal blood pressure during surgery for bleeding in the abdomen or chest will result in decreased bleeding and decreased chance of death.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
271

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

4 years

First QC Date

April 9, 2007

Last Update Submit

November 30, 2010

Conditions

Hemorrhagic ShockTraumaWounds, PenetratingShock, TraumaticMultiple Trauma

Keywords

Hypotensive ResuscitationHypotensive AnesthesiaHemorrhagic ShockPenetrating Trauma

Outcome Measures

Primary Outcomes (1)

  • 30 day survival

    30 days

Secondary Outcomes (14)

  • Sequential Organ Failure Assessment (SOFA) score

    30 days

  • APACHE II

    30 days

  • ARDS

    30 days

  • ICU length of stay

    30 days

  • Ventilator-free days

    30 days

  • +9 more secondary outcomes

Study Arms (2)

Low MAP Group

EXPERIMENTAL

Hypotensive Group with a target minimum MAP of 50 mmHg

Procedure: Intraoperative Hypotensive Resuscitation

High MAP group

NO INTERVENTION

Non experimental group: These patients will have a target minimum MAP of 65 mm Hg

Interventions

Intraoperative Hypotensive ResuscitationPROCEDURE

Patients will have a target minimum MAP of 50 for the case

Low MAP Group

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All adult patients seen in the Ben Taub emergency center that have suffered a trauma, have a systolic blood pressure less than 90mm Hg, and are going to the operating room for a laparotomy or thoracotomy

You may not qualify if:

  • Known or suspected head injury
  • Age \> 45 years old, \<= 12 years old
  • Incarcerated individuals
  • Pregnant women
  • Patients with an advanced directive that refuse resuscitation
  • Patients with "opt-out" bracelets that signify their refusal of participation in the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Shock, HemorrhagicWounds and InjuriesWounds, PenetratingShock, TraumaticMultiple Trauma

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Matthew M Carrick, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew M Carrick, MD

CONTACT

713-873-4381mcarrick@bcm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations

US(1)