NCT07530653

Brief Summary

This study will provide information on the quality of care in hemorrhagic shock of severe injuries in a limited resource facility of Latin America, the strategies of fluid resuscitation, and outcomes.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
716

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Oct 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 9, 2026

Last Update Submit

May 25, 2026

Conditions

Trauma and Emergency CareShock,HemorrhagicIntravenous Fluid Therapy

Keywords

Severe TraumaHemorrhagic shockNon-compresible torso injuriesDelayes resuscitationPermissive hypotensionIV fluidsLow-resource settingsLatin AmericaTrauma systems

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    Mortality on discharge or before 28 days.

    28 days

Secondary Outcomes (2)

  • Early mortality

    24 hours.

  • Coagulopathy

    24 hours.

Study Arms (2)

Delayed resuscitation

IV fluids lower than 1000 mL.

Drug: Crystalloid below 1000 mL.

Immediate resuscitation

IV fluids \> 1000 mL

Drug: IV fluids more than 1,000 mL

Interventions

IV fluids more than 1,000 mLDRUG

Prehospital IV fluids more than 1,000 mL.

Also known as: High volume resuscitation
Immediate resuscitation
Crystalloid below 1000 mL.DRUG

Administration of IV fluids below 1,000 mL on prehospital care.

Also known as: Restricted IV fluids, Permissive hypotension
Delayed resuscitation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypotensive patients in the emergency department or prehospital care caused by penetrating or blunt injuries.

You may qualify if:

  • Major injuries.
  • ISS \>15.
  • Hypotension with a systolic blood pressure below 90 mmHg.
  • No previous hospital care.
  • Older than 16 years.

You may not qualify if:

  • Brain injuries.
  • Pregnancy.
  • Drowning.
  • Burns.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (6)

  • Deeb AP, Lu L, Guyette FX, Peitzman AB, Daley BJ, Miller RS, Harbrecht BG, Phelan HA, Sperry JL, Brown JB. Optimal Prehospital Crystalloid Resuscitation Volume in Trauma Patients at Risk for Hemorrhagic Shock. J Am Coll Surg. 2023 Aug 1;237(2):183-194. doi: 10.1097/XCS.0000000000000695. Epub 2023 Mar 28.

    PMID: 36975122RESULT

  • Bernhardt IM, Moore EE, Sauaia A, Cotton BA, Cannon JW, Schreiber MA, Namias N, Minei JP, Wisniewski SR, Guyette FX, Sperry JL; Shock, Whole Blood, and Assessment of Traumatic Brain Injury (SWAT) Study Group. Timing of trauma deaths due to uncontrolled bleeding have not changed in three decades: A multicenter study of patients in hemorrhagic shock. Am J Surg. 2025 Dec;250:116510. doi: 10.1016/j.amjsurg.2025.116510. Epub 2025 Jul 8.

    PMID: 40706451RESULT

  • Pinsky MR. The Effective Management of Shock: Moving From Physiology to Guidelines to Personalized Medicine. Crit Care Med. 2026 Mar 17. doi: 10.1097/CCM.0000000000007115. Online ahead of print.

    PMID: 41841954RESULT

  • Penn J, McAleer R, Ziegler C, Cheskes S, Nolan B, von Vopelius-Feldt J. Effectiveness of Prehospital Critical Care Scene Response for Major Trauma: A Systematic Review. Prehosp Emerg Care. 2026;30(2):309-322. doi: 10.1080/10903127.2025.2483978. Epub 2025 Apr 1.

    PMID: 40131291RESULT

  • Gnanou S, Guertin JR, Tardif PA, Conombo B, Berube M, Yanchar N, Berthelot S, Gnanvi J, Moore L. Cost-effectiveness of specialized trauma care: A systematic review. J Health Serv Res Policy. 2026 Jan;31(1):56-67. doi: 10.1177/13558196251348409. Epub 2025 Jun 4.

    PMID: 40464624RESULT

  • Bickell WH, Wall MJ Jr, Pepe PE, Martin RR, Ginger VF, Allen MK, Mattox KL. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med. 1994 Oct 27;331(17):1105-9. doi: 10.1056/NEJM199410273311701.

    PMID: 7935634RESULT

MeSH Terms

Conditions

Wounds and InjuriesShock, Hemorrhagic

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Norton Perez, MD

    Hospital Departamental de Villavicencio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Norton Perez, MD

CONTACT

+573112517471norton.perez@hotmail.com

Emma I Rodriguez Darabos, MSc

CONTACT

3112517538emmaisa1@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICU director

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Patient's information included.

Locations

CO(1)