DEXTROSE 50% (dextrose)
**Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A** is an anticoagulant intended for use only with medical devices that prepare Platelet Rich Plasma (PRP) products. It is used to maintain blood fluidity during extracorporeal processing, ensuring that blood samples do not clot while being refined into PRP for medical procedures.
How DEXTROSE 50% Works
This solution functions as an extracorporeal anticoagulant through its primary component, **sodium citrate**, which binds free calcium ions in the blood. Because calcium is a necessary co-factor for multiple steps in the clotting cascade, its sequestration prevents the formation of clots outside the body. The solution also contains dextrose to maintain isotonicity and citric acid for pH regulation. It exerts no systemic pharmacological effect.
Details
- Status
- Prescription
- First Approved
- 1986-06-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEXTROSE 50% Approval History
What DEXTROSE 50% Treats
2 indicationsDEXTROSE 50% is approved for 2 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Extracorporeal anticoagulation
- Preparation of Platelet Rich Plasma (PRP) products
DEXTROSE 50% Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DEXTROSE 50%
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07494084 | R01HL177106 R01HL177106 | Ph 4 | not yet recruiting | Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance |
| NCT04895358 | 3475-B49 MK-3475-B49, KEYNOTE-B49 | Ph 3 | active not recruiting | Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) |
| NCT05264727 | 22-000306 R01DK116231 | Ph 4 | active not recruiting | Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion |
| NCT04020601 | Pro00092897 | Ph 2, Ph 3 | terminated | The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty |
| NCT02471690 | MDCO-ORI-15-01 | Ph 1 | completed | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers |
| NCT03095651 results posted | 5160-002 MK-5160-002 | Ph 1 | completed | Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002) |
| NCT02269735 | 2640-001 | Ph 1 | completed | A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) |
| NCT00578669 results posted | PHI0710-002 1R01DA023190 | Ph 3 | completed | Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms |
| NCT01547364 | SweetCaudal | Ph 2 | completed | Caudal Epidural Injection of Dextrose For Low Back Pain |
| NCT02984098 40%D-N-PP | POSDRU/159.5/S/133377 | Ph 4 | completed | 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose |
| NCT02185729 TPN1 results posted | IRB00007543 | Ph 2, Ph 3 | completed | Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers |
| NCT00878878 results posted | GE-191-004 | Ph 4 | completed | Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR). |
| NCT01326611 | rö05053781128 | Ph 4 | completed | Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEXTROSE 50% FDA Label Details
Indications & Usage
FDA Label (PDF)DEXTROSE 50% is indicated for the treatment of Extracorporeal anticoagulation; Preparation of Platelet Rich Plasma (PRP) products.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.