Comparison between two methods for treating severe bleeding due to severe injury: giving Massive Blood Transfusion in one group and adding early Cryoprecipitate along with Massive Blood Transfusion in the other group and assessing the usefulness and side effects of using cryoprecipitate

Standard Haemorrhage Protocol vs Standard Haemorrhage Protocol and Early Cryoprecipitate for Resuscitation in Major Haemorrhage in Patients of Trauma: A Parallel Arm Single Blinded Randomized Control Trial Using Block Randomization. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075897

Enrollment

Registered

2024-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: T798- Other early complications of trauma

Interventions

Intervention1: Cryoprecipitate: Cryoprecipitate is also known as cryoprecipitated antihemophilic factor. Cryoprecipitate is made by thawing FFP at 1–6 °C. During this thawing process, a precipitate fo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Judged to be an adult at the time of screening (if identity not known) 2. Candidate 18 years or older but below 60 3. Evidence of active hemorrhage requiring activation of Massive Blood Transfusion Protocol 4. Severe injury as characterized by Injury Severity Score of more or equal to 16

Exclusion criteria

Exclusion criteria: 1. Trauma presenting outside 12 hours of injury 2. Injuries incompatible with life as judged by the Department of Trauma and Emergency at AIIMS Nagpur. 3. Age less than 18 and more than 60 years. 4. Injury Severity Score of less than 16. 5. Severe Traumatic Brain Injury

Design outcomes

Primary

Measure	Time frame
To evaluate the trends in immediate and short-term "all cause" mortality after administration of empirical high dose cryoprecipitate in patients of severe trauma in comparison with those treated with only Massive Blood Transfusion.Timepoint: From the date of presentation to hospital to 5 days	—

Secondary

Measure	Time frame
1. To evaluate time to arrest of active bleeding 2. To assess the timing of resolution of hemorrhagic shock. 3. To determine the requirement of blood products in patients of trauma who had received early empirical high-dose cryoprecipitate along with activation of MBTP. 4. To compare the incidence of MODS in these patients 5. To compare the incidence of TRALI and TACO in patients requiring MBT and those being given MBT + Cryoprecipitate 6. To compare the incidence of early post-thrombotic events in patients on a 5 day follow-up. Timepoint: From the date of presentation to hospital to 5 days	—

Measure

Time frame

1. To evaluate time to arrest of active bleeding 2. To assess the timing of resolution of hemorrhagic shock. 3. To determine the requirement of blood products in patients of trauma who had received early empirical high-dose cryoprecipitate along with activation of MBTP. 4. To compare the incidence of MODS in these patients 5. To compare the incidence of TRALI and TACO in patients requiring MBT and those being given MBT + Cryoprecipitate 6. To compare the incidence of early post-thrombotic events in patients on a 5 day follow-up. Timepoint: From the date of presentation to hospital to 5 days

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Countries

India

Contacts

Public ContactDr Abhishek Rana

AIIMS Nagpur

drmahendrak@rediffmail.com7768067481

Outcome results

None listed

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