Major TraumaNCT06103292
Calcium Levels in Major Trauma
An observational study of Major Trauma, run by Hossam Abdel Rahman Ahmed Ismail.
Trial summary
To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Trauma
- What is being tested?
- ionized calcium levels
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- >18 years old - < 70 years
- Major trauma patients.
- Admission and Ionized calcium measurement before blood transfusions
Who cannot join
- patients below 18 years or > 70 years of age.
- Pregnant women
- Arrested patients
- Patients managed outside the hospital and had received blood transfusions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ionized Calcium Level Abnormalities In Major Trauma Patients Pre And Post Receiving Blood Transfusion And Its Relation To Mortality Rate
To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions .
Read the detailed description
Primary objective:
- to evaluate the level of ionized calcium in multiple trauma patients with massive hemorrhage
Secondary objective:
- to build a relation between the level of ionized calcium and the degree of hemorrhagic shock
- Conditions
- Major Trauma
- Being tested
- ionized calcium levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ionized calcium levelsDiagnostic test
measuring calcium level in trauma patients
What is being measured
The primary outcome is the main question the study is designed to answer.
follow up ionized calcium level
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startMar 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hossam Abdel Rahman Ahmed Ismail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hossam Abdel Rahman Ahmed Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103292
- Sponsor's protocol ID
- Calcium abnormaities in trauma
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7869433Heckbert 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.
PubMed 9751548Zink 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.
PubMed 19393349Barry 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.
PubMed 5551141
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ionized Calcium Level Abnormalities In Major Trauma Patients Pre And Post Receiving Blood Transfusion And Its Relation To Mortality Rate
- ClinicalTrials.gov ID
- NCT06103292
- Acronym / sponsor ID
- Calcium abnormaities in trauma
- Conditions
- Major Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hossam Abdel Rahman Ahmed IsmailUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions .
Detailed description
Primary objective:
- to evaluate the level of ionized calcium in multiple trauma patients with massive hemorrhage
Secondary objective:
- to build a relation between the level of ionized calcium and the degree of hemorrhagic shock
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- >18 years old - < 70 years
- Major trauma patients.
- Admission and Ionized calcium measurement before blood transfusions
Key exclusion criteria (4 listed)
- patients below 18 years or > 70 years of age.
- Pregnant women
- Arrested patients
- Patients managed outside the hospital and had received blood transfusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ionized calcium levelsmeasuring calcium level in trauma patients | Diagnostic test | – |
Primary outcome
follow up ionized calcium level
Time frame: 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 7869433Sauaia 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.
- Background: PubMed 9751548Heckbert 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.
- Background: PubMed 19393349Zink 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.
- Background: PubMed 5551141Barry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Trauma, run by Hossam Abdel Rahman Ahmed Ismail.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HOSSAM ISMAIL, MBBCH (+201090703142, hosoabdo1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow up ionized calcium level (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103292, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.