NCT05634109 (WEBSTER) is a Phase 3 clinical trial of Transfusion of blood products in Trauma, sponsored by Fundacion Clinica Valle del Lili.

Who is sponsoring NCT05634109?

NCT05634109 is sponsored by Fundacion Clinica Valle del Lili.

What drugs are being tested in NCT05634109?

Interventions in NCT05634109: Transfusion of blood products.

What condition does NCT05634109 study?

NCT05634109 studies Trauma, Trauma Injury, Trauma, Multiple.

Is NCT05634109 still recruiting?

NCT05634109 is currently recruiting now. Last updated 24 February 2025.

Last reviewed 2025-02-24 · How we verify

NCT05634109: WEBSTER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial

Recruiting now Phase 3 Last updated 24 February 2025

What this trial tests

Phase 3 trial testing Transfusion of blood products in Trauma in 220 participants. Currently enrolling.

Timeline

14 January 2023

Primary endpoint
1 December 2025

1 March 2026

Quick facts

Lead sponsor	Fundacion Clinica Valle del Lili
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	220
Start date	14 January 2023
Primary completion	1 December 2025
Estimated completion	1 March 2026
Sites	1 location across Colombia

Drugs / interventions tested

Transfusion of blood products — full drug profile →

Conditions studied

Trauma — all drugs for Trauma →
Trauma Injury — all drugs for Trauma Injury →
Trauma, Multiple — all drugs for Trauma, Multiple →

Sponsor

Fundacion Clinica Valle del Lili

Who can join

18 and older, any sex, with Trauma or Trauma Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The primary outcome is a hierarchical outcome consisting of mortality at 28 days post-randomization and evolution of organ dysfunction (difference of Sequential Organ Failure Assessment (SOFA) score between day 1 and day 5 post-randomization).
Time frame: 28 days post ED admission
The primary outcome is a hierarchical composite outcome that will be analyzed using the Win-Ratio test. The first level will be 28-day mortality. The "winner" will be the participant who survival; in case of a tie, the second level will be the difference in SOFA score between fifth and first day. The "winner" will be participant with the lowest difference.

Sponsor's own description

This study aims to evaluate among trauma patients with hemorrhagic shock the clinical impact of hemostatic resuscitation between whole blood vs. blood components therapy in the following outcomes in a hierarchical analysis: mortality at 28 days and evolution of organ dysfunction.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Blood transfusion strategies for major bleeding in trauma.
Brunskill SJ, Disegna A, Wong H, Fabes J, et al · · 2025 · cited 4× · PMID 40271704 · DOI 10.1002/14651858.cd012635.pub2
Transfusion of modified whole blood versus blood components therapy in patients with severe trauma: Randomized controlled trial protocol (WEBSTER trial).
García AF, Caicedo Y, Gempeler A, Vallecilla L, et al · · 2025 · cited 1× · PMID 40087111 · DOI 10.1016/j.injury.2025.112173

Verify or expand the search:

Other trials of Transfusion of blood products

Trials testing the same drug.

NCT03313583 — French One Day Survey in 2011 - Knowing Our Population of Labile Blood Products Recipients · completed

Other recruiting trials for Trauma

Currently open trials in the same condition.

NCT07290634 — Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion · recruiting
NCT07485231 — Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD · NA · recruiting
NCT07473336 — The Effectiveness of RAPID-Based Psychological First Aid Training · NA · active not recruiting
NCT07278505 — Study of Cannabidiol and Neuroimaging on Stress · Phase 1, PHASE2 · recruiting
NCT02880163 — REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam · NA · recruiting

Other Fundacion Clinica Valle del Lili trials

Trials by the same sponsor.

NCT06875791 — Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients. · Phase 1, PHASE2 · not yet recruiting
NCT06843265 — Outcomes and Perceptions of the Implementation of the JADA Device in a Stage II Postpartum Hemorrhage Management Protoco · NA · not yet recruiting
NCT06620432 — High Vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean · NA · not yet recruiting
NCT06086080 — Non-operative Treatment in First-time Patellar Dislocation · NA · recruiting
NCT05922397 — Placenta Accreta Spectrum Topographic Classification · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05634109 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundacion Clinica Valle del Lili
Last refreshed: 24 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05634109.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing