DEXTROSE 5% AND SODIUM CHLORIDE 0.9% (dextrose)
Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is an anticoagulant intended for use during the preparation of Platelet Rich Plasma (PRP) products. It is used exclusively with medical devices designed for extracorporeal blood processing to prevent blood from clotting while it is being processed outside the body.
How DEXTROSE 5% AND SODIUM CHLORIDE 0.9% Works
This solution acts as an extracorporeal anticoagulant through its sodium citrate component, which binds free calcium ions in the blood. Because calcium is a necessary co-factor for multiple steps in the coagulation cascade, its sequestration prevents the blood from clotting. The solution also contains citric acid for pH regulation and dextrose to maintain isotonicity.
Details
- Status
- Prescription
- First Approved
- 2020-09-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% Approval History
What DEXTROSE 5% AND SODIUM CHLORIDE 0.9% Treats
1 FDA approvalsOriginally approved for its first indication in 2020 .
- Other (1)
Other
(1 approval)- • Approved indication (Sep 2020)
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 5% AND SODIUM CHLORIDE 0.9% FDA Label Details
Indications & Usage
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. [See Dosage and Administration .] ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See the device operator's manual for additional information and complete usage instructions.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.