NCT07188766Recruiting
Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis
Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 394 (estimated)
- First submitted
- 11 Aug 2025
- Start date
- 5 Oct 2025
- Primary completion date
- Aug 2028
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Diseases
- Sickle cell disease
- NCT number
- NCT07188766
What you commit to
- Study type: Interventional
- Planned participants: 394
- From 5 Oct 2025 to the primary completion date, Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously enrolled in this trial within the last 30 days
Other illness
- Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure
Other
- Patient requiring specialized IVF management as per the treating physician discretion.
- Patients with ESRD on chronic dialysis
- Patients with signs of shock (low SBP \<100 or MAP \< 65) and signs of hypo perfusion
- Known or suspected pregnancy
- Enrolled in another trial study that interfered with fluid management
- Unable to obtain IV access.
Who the study is looking for
- Patients \>18 years old with a confirmed diagnosis of SCD.
- Presenting with a VOC.
- NPRS \>5
- Willingness to participate and provide informed consent.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Fahd Hospital of the University Coordinator of this site? Confirm its status | Dammam | Saudi Arabia | Recruiting |
| King Saud University Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.