Randomized, Open labelled, Phase IIa /IIb Clinical trials to study the safety and efficacy of intravenous estrogen therapy in reducing the incidence of sepsis/septic shock in Trauma Hemorrhagic Shock patients

Randomized, Open labelled, Phase IIa /IIb Clinical trial to study the safety and efficacy of intravenous estrogen therapy in reducing the incidence of sepsis/septic shock in Trauma Hemorrhagic Shock patients - PROTECT-THS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073380

Enrollment

120

Registered

2024-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: D683- Hemorrhagic disorder due to circulating anticoagulants

Interventions

Intervention1: IV-Estrogen: Administration of intravenous IV conjugated estrogen in humans following trauma hemorrhage have several beneficial effects such as early recovery, protection from sepsis as

Eligibility

Inclusion criteria

Inclusion criteria: Trauma victims with hemorrhagic-shock Age group >18 and Systolic Blood Pressure (SBP) of =90 mmHg Patients or proxy willing to provide informed consent Patients admitted within 8 h of injury

Exclusion criteria

Exclusion criteria: Age group 45 years SBP >90 mmHg Patients already resuscitated with colloids/crystalloids before reporting to the Emergency Department Patients admitted after 8 h of injury

Design outcomes

Primary

Measure	Time frame
To study the safety and dose optimization of IV estrogen in trauma hemorrhagic shock patients as compared to the placebo group (Phase IIa). To study the efficacy of IV estrogen attenuating sepsis/septic shock in trauma hemorrhagic shock patients as compared to the placebo group (Phase IIb). Timepoint: Time Frame: Day 0, 3, 7 and 14	—

Secondary

Measure	Time frame
Correlation of dose regimen with the incidence of sepsis/septic shock in the Premarin® group as compared to placebo group (Time Frame: Day 0, 3, 7 and 14 ) Correlation of dose regimen on immune alterations with the incidence of sepsis/septic shock in the Premarin® group as compared to placebo group (Time Frame: Day 0, 3, 7 and 14) Correlation of dose regimen with the survival or death in the Premarin® group as compared to placebo group (Time Frame: Day 0, 3, 7 and 14 and/or after following 1 year) Correlation of estrogen serum concentration with the incidence of sepsis/septic shock in the Premarin® group as compared to estrogen baseline concentration of placebo group (Time Frame: Day 0, 3, 7 and 14) Timepoint: Time Frame: Day 0, 3, 7 and 14. The survival or death of the patient will be followed up to 1 to 2 years and correlate with the immune alterations as mentioned.	—

Measure

Time frame

Correlation of dose regimen with the incidence of sepsis/septic shock in the Premarin® group as compared to placebo group (Time Frame: Day 0, 3, 7 and 14 ) Correlation of dose regimen on immune alterations with the incidence of sepsis/septic shock in the Premarin® group as compared to placebo group (Time Frame: Day 0, 3, 7 and 14) Correlation of dose regimen with the survival or death in the Premarin® group as compared to placebo group (Time Frame: Day 0, 3, 7 and 14 and/or after following 1 year) Correlation of estrogen serum concentration with the incidence of sepsis/septic shock in the Premarin® group as compared to estrogen baseline concentration of placebo group (Time Frame: Day 0, 3, 7 and 14) Timepoint: Time Frame: Day 0, 3, 7 and 14. The survival or death of the patient will be followed up to 1 to 2 years and correlate with the immune alterations as mentioned.

—

Countries

India

Contacts

Public ContactSanjeev Bhoi

All India Institute of Medical Sciences

Sanjeevbhoi@gmail.com8527050391

Outcome results

None listed

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