FLASCNCT07188766

Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis

StatusRecruiting

PhaseNot applicable

SponsorImam Abdulrahman Bin Faisal University

Primary completionAug 2028 (estimated)

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 9, 2026 Eligibility criteria expanded, about 12 words
- Trial sites expanded: 2 → 5 locations
- Study description expanded, about 6 words
- Publications: details revised at 6 of 6 entries
Notable Mar 16, 2026 Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
- Primary completion date: Oct 2026 to Aug 2028
- Eligibility criteria shortened, about 6 words
- Study sites: 0 to 2
- Study completion date: Oct 2026 to Oct 2028
- Start date changed from estimate of Oct 2025 to Oct 5, 2025
- Study description expanded, about 6 words
Sep 16, 2025 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Change in Pain intensity

Timeframe: Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- 48- and 72-hours post-admission ( for admitted patients)

Secondary (7)

Time to pain resolution

ED length of stay

Hospital admission rate

Cumulative Opioid Dose

Revisit Rates

Show 2 moreShow less

Overall Mortality

Adverse events

Arms and interventions

Restricted approach groupExperimental

Patients in this arm will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered

Liberal Approach GroupActive comparator

Patients will receive an IV bolus of 20 mL/kg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements

Drugs: Sodium Chloride (NaCl) 0.9 %

Sites

5 sites in 1 country

About this trial

Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. This study evaluates restrictive versus liberal fluid management strategies in patients with acute VOC. This multi-center, open-label, non-inferiority RCT will enroll patients with SCD presenting with acute VOC. Participants will be randomized to either a restrictive or liberal intravenous fluid management protocol. Primary outcome is pain score reduction. Secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid dose, adverse events (incidence of fluid overload, pulmonary congestion), acute chest syndrome, incidence of acute kidney injury, revisit rates within 72 hours of ED discharge, need for intensive care or high-dependency unit admission, need for additional interventions, and 28 days overall mortality. Data will be analyzed using intention-to-treat principles. We hypothesize that a restrictive fluid strategy will achieve non-inferior pain control compared to a liberal strategy, while minimizing fluid-related complications. This study will provide evidence to inform clinical guidelines for fluid management in SCD patients experiencing VOCs.

Trial details

Enrollment: 394 participants (estimated)
Started: Oct 5, 2025
Study completion: Oct 2028 (estimated)
Eligibility: 18 to 60, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Oversight: Data monitoring committee
Conditions: Anemia, Sickle Cell, Emergencies, Vaso-Occlusive Crises, SCD, Vaso Occlussive Crisis
Official title: Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)
First posted: Sep 23, 2025
Registry updated: Nov 10, 2026
Last verified: Nov 2026

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