NCT06103292

Brief Summary

To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 22, 2023

Last Update Submit

October 22, 2023

Conditions

Major Trauma

Outcome Measures

Primary Outcomes (1)

  • follow up ionized calcium level

    24 hrs

Interventions

ionized calcium levelsDIAGNOSTIC_TEST

measuring calcium level in trauma patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this study all consecutive adult multiple trauma patients presenting to the emergency department with the inclusion criteria until the sample size is satisfied.

You may qualify if:

  • \>18 years old - \< 70 years
  • Major trauma patients.
  • Admission and Ionized calcium measurement before blood transfusions

You may not qualify if:

  • patients below 18 years or \> 70 years of age.
  • Pregnant women
  • Arrested patients
  • Patients managed outside the hospital and had received blood transfusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Sauaia A, Moore FA, Moore EE, Moser KS, Brennan R, Read RA, Pons PT. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995 Feb;38(2):185-93. doi: 10.1097/00005373-199502000-00006.

    PMID: 7869433BACKGROUND

  • Heckbert SR, Vedder NB, Hoffman W, Winn RK, Hudson LD, Jurkovich GJ, Copass MK, Harlan JM, Rice CL, Maier RV. Outcome after hemorrhagic shock in trauma patients. J Trauma. 1998 Sep;45(3):545-9. doi: 10.1097/00005373-199809000-00022.

    PMID: 9751548BACKGROUND

  • Zink KA, Sambasivan CN, Holcomb JB, Chisholm G, Schreiber MA. A high ratio of plasma and platelets to packed red blood cells in the first 6 hours of massive transfusion improves outcomes in a large multicenter study. Am J Surg. 2009 May;197(5):565-70; discussion 570. doi: 10.1016/j.amjsurg.2008.12.014.

    PMID: 19393349BACKGROUND

  • Barry GD. Plasma calcium concentration changes in hemorrhagic shock. Am J Physiol. 1971 Apr;220(4):874-9. doi: 10.1152/ajplegacy.1971.220.4.874. No abstract available.

    PMID: 5551141BACKGROUND

Central Study Contacts

HOSSAM ISMAIL, MBBCH

CONTACT

+201090703142hosoabdo1996@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hossam Ismail

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

March 1, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share