Trial intelligence / Profile preview

TXA in Humerus ORIF

NCT05802238Phase 2

Key facts

Status: Withdrawn
Start: Apr 2023
Primary completion: Nov 2024
Countries: 1
Sponsor: Allegheny Singer Research Institute
Modality: Small Molecules

Drugs: tranexamic acid
Conditions: humerus fracture

Overview

Phase 2, randomised, open-label trial of tranexamic acid in humerus fracture (2 arms), sponsored by Allegheny Singer Research Institute. Primary endpoint: Intraoperative Blood Loss. Planned start Apr 2023; status: withdrawn.

Design

2 arms

Study design: RandomizedOpen-label

Treatment Arm
Tranexamic acid (TXA) administered 10 minutes prior to surgery
Control Group
Saline administered 10 minutes prior to surgery

Who it enrols

Adults 18-100 with isolated proximal humerus or humeral shaft fracture undergoing ORIF. Excludes history of thrombosis, allergy to TXA, color vision disturbance, pregnancy, recent MI/stent, renal impairment, refusal of blood products, SAH, DIC.

Endpoints

Primary

Intraoperative Blood LossIntraoperatively

Secondary

Operative TimeIntraoperatively
Duration of follow-up1 year
Complications (DVT, PE, stroke)1 year

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