Overview
Hydroxyethyl starch (HES/HAES) is a nonionic starch derivative. Hydroxyethyl starches (HES) are synthetic colloids commonly used for fluid resuscitation to replace intravascular volume. HES is a general term and can be sub-classified according to average molecular weight, molar substitution, concentration, C2/C6 ratio and Maximum Daily Dose.
Background
Hydroxyethyl starch (HES/HAES) is a nonionic starch derivative. Hydroxyethyl starches (HES) are synthetic colloids commonly used for fluid resuscitation to replace intravascular volume. HES is a general term and can be sub-classified according to average molecular weight, molar substitution, concentration, C2/C6 ratio and Maximum Daily Dose.
Indication
An intravenous solution of hydroxyethyl starch is used to prevent shock following severe blood loss caused by trauma, surgery, or other issues.
Associated Conditions
- Hypovolaemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/29 | Phase 4 | Not yet recruiting | Xiangya Hospital of Central South University | ||
2022/07/27 | Not Applicable | Recruiting | General Hospital of Ningxia Medical University | ||
2022/07/27 | Not Applicable | Completed | General Hospital of Ningxia Medical University | ||
2020/09/28 | N/A | Completed | The George Institute for Global Health, Australia | ||
2018/09/19 | Not Applicable | Completed | Holbaek Sygehus | ||
2018/03/15 | Early Phase 1 | UNKNOWN | |||
2017/11/22 | Phase 4 | Completed | |||
2017/11/09 | Phase 4 | Completed | |||
2017/10/11 | Not Applicable | Completed | |||
2017/09/11 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1317 | INTRAVENOUS | 6 g in 100 mL | 1/29/2024 | |
| Hospira, Inc. | 0409-1555 | INTRAVENOUS | 6 g in 100 mL | 2/15/2023 | |
| Hospira, Inc. | 0409-7248 | INTRAVENOUS | 6 g in 100 mL | 7/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VOLUVEN SOLUTION FOR INFUSION 6% | SIN12297P | INJECTION | 60 g/l | 5/16/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hydroxyethyl Starch 20 Sodium Chloride Injection | 国药准字H20033771 | 化学药品 | 注射剂 | 7/23/2020 | |
| Hydroxyethyl Starch 20 Sodium Chloride Injection | 国药准字H37023644 | 化学药品 | 注射剂 | 6/30/2020 | |
| Hydroxyethyl Starch 20 Sodium Chloride Injection | 国药准字H20013073 | 化学药品 | 注射剂 | 6/30/2020 | |
| Hydroxyethyl Starch 20 Sodium Chloride Injection | 国药准字H19999409 | 化学药品 | 注射剂 | 9/10/2020 | |
| Hydroxyethyl Starch 20 Sodium Chloride Injection | 国药准字H20033770 | 化学药品 | 注射剂 | 7/23/2020 | |
| Hydroxyethyl Starch 20 Sodium Chloride Injection | 国药准字H32020977 | 化学药品 | 注射剂 | 7/30/2020 | |
| Hydroxyethyl Starch 20 Sodium Chloride Injection | 国药准字H62021260 | 化学药品 | 注射剂 | 11/17/2020 | |
| Hydroxyethyl Starch 130/0.4 and Electrolyte Injection | 国药准字H20193403 | 化学药品 | 注射剂 | 12/26/2019 | |
| Hydroxyethyl Starch 130/0.4 and Electrolyte Injection | 国药准字H20193404 | 化学药品 | 注射剂 | 12/26/2019 | |
| Hydroxyethyl Starch 130/0.4 and Electrolyte Injection | 国药准字H20130006 | 化学药品 | 注射剂（大容量注射剂） | 8/18/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VOLULYTE 6% SOLUTION FOR INFUSION | N/A | N/A | N/A | 7/20/2009 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VOLUVEN 6% hydroxyethyl starch 130/0.4 250 mL solution for intravenous infusion bag | 120359 | Medicine | A | 11/13/2006 | |
| VOLUVEN 6% hydroxyethyl starch 130/0.4 500 mL solution for intravenous infusion bag | 120361 | Medicine | A | 11/13/2006 | |
| VOLUVEN 6% hydroxyethyl starch 130/0.4 500 mL solution for intravenous infusion bottle | 120358 | Medicine | A | 11/13/2006 | |
| VOLULYTE 6% | 172173 | Medicine | A | 8/26/2011 | |
| VOLUVEN 6% hydroxyethyl starch 130/0.4 250 mL solution for intravenous infusion bottle | 120276 | Medicine | A | 11/13/2006 | |
| VOLULYTE 6% | 187473 | Medicine | A | 8/26/2011 |