Role of IV Estrogen in trauma hemorrhagic shock patients

To Study the safety and efficacy of intravenous Estrogen as therapeutic adjunct for treatment of hemorrhagic shock patient presenting to the emergency department of a level 1 trauma centre - REST - Trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/12/004181

Enrollment

Registered

2013-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Trauma Hemorrhagic Shock

Interventions

Intervention1: IV Conjugated Estrogen: single bolus dose of 25mg injection contains amixture of conjugated estrogen obtained exclusively from natural sources,occuring as the sodium salts of water-solu

Eligibility

Inclusion criteria

Inclusion criteria: • Trauma victims • Systolic Blood pressure (SBP) of • Estimated time to study drug administration • Glasgow coma scale (GCS) score of between 3 and 8 prior to intubations and/or sedation, due to difficulty of patients cooperation in assessment after these intervention

Exclusion criteria

Exclusion criteria: • Age: Less than 18 years • Known incarcerated individual • Cardiopulmonary resuscitation (CPR) prior to study drug administration • Known contraindication for estrogen (male sex is NOT a contraindication) • Patients already resuscitated with colloids or crystalloids before reporting to the emergency department. • Pregnant lady • Non hemorrhagic-shock: 1- Tension pnumothorax 2- Septic 3- Neurogenic • Previous history of thrombosis events such as DVT (Deep venous thrombosis) • Injury time unknown • Drug Medication: 1. Intravenous drug abuse 2. oral contraceptive 3. Estrogen 4. Heparin induced thrombocytopenia • Stroke

Design outcomes

Primary

Measure	Time frame
â?¢ Efficacy of intravenous estrogen in terms of survival or death. Timepoint: 0 day,3 day, 7th day,14th day	—

Secondary

Measure	Time frame
â?¢ To analysis the effect of estrogen on immunological alternation and its correlation with survival or death. 2. Time frame: 1,3, 7, and 14 days â?¢ To study the role of estrogen on development of sepsis with or without muliorgan failure (MOF) on days 1, 3, 7, and 14. â?¢ Survival or death on days 30 and 1 year of follow-up. â?¢ To observe the adverse effect of estrogen: 1. Minor events 2. Major events 3. Other thrombosis events Timepoint: Time frame: 1,3, 7, and 14 days	—

Measure

Time frame

â?¢ To analysis the effect of estrogen on immunological alternation and its correlation with survival or death. 2. Time frame: 1,3, 7, and 14 days â?¢ To study the role of estrogen on development of sepsis with or without muliorgan failure (MOF) on days 1, 3, 7, and 14. â?¢ Survival or death on days 30 and 1 year of follow-up. â?¢ To observe the adverse effect of estrogen: 1. Minor events 2. Major events 3. Other thrombosis events Timepoint: Time frame: 1,3, 7, and 14 days

—

Countries

India

Contacts

Public ContactDr Sanjeev Bhoi

All India Institute of Medical Sciences

sanjeevbhoi@gmail.com9868397053

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026