Blood Loss, SurgicalNCT04622397
Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
A study testing Tranexamic acid injection and Saline in people with Blood Loss, Surgical and Scoliosis, run by Cairo University.
Trial summary
We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Blood Loss, Surgical, Scoliosis
- What is being tested?
- Tranexamic acid injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2021to 29 Dec 2021
- Phase
- Interventional
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-12 years
- Of both sexes
- American society of anesthesiologist (ASA) physical status classification class I
- Undergoing general anesthesia for scoliosis surgery
Who cannot join
- Parents' refusal of regional block
- Known allergy to tranexamic acid
- Bleeding disorders (INR >1.4,Platelet count< 75000)
Trial locations and contacts
No sites are listed yet.
About this study
We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery
Read the detailed description
Spine surgery in paediatrics is frequently associated with substantial blood loss.
Blood product adminestration in children has many complications that are not fully known.
There are many modalities currently available to reduce blood loss in pediatric patients.
Tranexamic acid is tissue plasminogen activator inhibitor that reduce perioperative blood loss.
To date, no studies have investigated effect of local administration of tranexamic acid in pediatric population undergoing scoliosis surgery.
- Conditions
- Blood Loss, Surgical, Scoliosis
- Being tested
- Tranexamic acid injection, Saline
- Medical subject headings
- Blood Loss, Surgical, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
SalineDrug
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
| Study group | Role | What they receive |
|---|---|---|
| Group T (tranexamic acid),n=15 | Active comparator | Group T: tranexamic acid 10 mg/kg will be injected locally Receives: Drug: Tranexamic acid injection |
| Group S (saline) (n=15) | Placebo comparator | Group S saline will be injected Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraperative blood loss in both groups
amount of blood/kg(ml/kg)
Measured: period of surgery(1-2 hours)
Secondary outcomes (2)
post-operative blood loss
amount of blood in drain after surgery
Measured: 24 hours
Blood product admenestration
units of blood given during surgery
Measured: duration of procedure(1-2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start10 Jan 2021 (estimated)
- Primary completion29 Nov 2021 (estimated)
- Study completion29 Dec 2021 (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 Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized comparative study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622397
- Sponsor's protocol ID
- tranexamic acid in scoliosis
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bible JE, Mirza M, Knaub MA. Blood-loss Management in Spine Surgery. J Am Acad Orthop Surg. 2018 Jan 15;26(2):35-44. doi: 10.5435/JAAOS-D-16-00184.
PubMed 29303921Goobie SM. A blood transfusion can save a child's life or threaten it. Paediatr Anaesth. 2015 Dec;25(12):1182-3. doi: 10.1111/pan.12816. No abstract available.
PubMed 26507915Mikhail C, Pennington Z, Arnold PM, Brodke DS, Chapman JR, Chutkan N, Daubs MD, DeVine JG, Fehlings MG, Gelb DE, Ghobrial GM, Harrop JS, Hoelscher C, Jiang F, Knightly JJ, Kwon BK, Mroz TE, Nassr A, Riew KD, Sekhon LH, Smith JS, Traynelis VC, Wang JC, Weber MH, Wilson JR, Witiw CD, Sciubba DM, Cho SK. Minimizing Blood Loss in Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):71S-83S. doi: 10.1177/2192568219868475. Epub 2020 Jan 6.
PubMed 31934525Slaughter TF, Greenberg CS. Antifibrinolytic drugs and perioperative hemostasis. Am J Hematol. 1997 Sep;56(1):32-6. doi: 10.1002/(sici)1096-8652(199709)56:13.0.co;2-3.
PubMed 9298865
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04622397
- Acronym / sponsor ID
- tranexamic acid in scoliosis
- Conditions
- Blood Loss, Surgical, Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (estimated)
- Primary completion
- 29 Nov 2021 (estimated)
- Study completion
- 29 Dec 2021 (estimated)
- First posted
- 10 Nov 2020 (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.
We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery
Detailed description
Spine surgery in paediatrics is frequently associated with substantial blood loss.
Blood product adminestration in children has many complications that are not fully known.
There are many modalities currently available to reduce blood loss in pediatric patients.
Tranexamic acid is tissue plasminogen activator inhibitor that reduce perioperative blood loss.
To date, no studies have investigated effect of local administration of tranexamic acid in pediatric population undergoing scoliosis surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- randomized comparative study
| Arm | Type | Receives |
|---|---|---|
| Group T (tranexamic acid),n=15 | Active comparator | Drug: Tranexamic acid injectionGroup T: tranexamic acid 10 mg/kg will be injected locally |
| Group S (saline) (n=15) | Placebo comparator | Drug: SalineGroup S saline will be injected |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 2-12 years
- Of both sexes
- American society of anesthesiologist (ASA) physical status classification class I
- Undergoing general anesthesia for scoliosis surgery
Key exclusion criteria (3 listed)
- Parents' refusal of regional block
- Known allergy to tranexamic acid
- Bleeding disorders (INR >1.4,Platelet count< 75000)
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 |
|---|---|---|
| Tranexamic acid injectionLocal subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision | Drug | Group T (tranexamic acid),n=15 |
| SalineLocal subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision | Drug | Group S (saline) (n=15) |
Primary outcome
Intraperative blood loss in both groups
Time frame: period of surgery(1-2 hours)
amount of blood/kg(ml/kg)
2 secondary outcomes
post-operative blood loss
Time frame: 24 hours
Blood product admenestration
Time frame: duration of procedure(1-2 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 29303921Bible JE, Mirza M, Knaub MA. Blood-loss Management in Spine Surgery. J Am Acad Orthop Surg. 2018 Jan 15;26(2):35-44. doi: 10.5435/JAAOS-D-16-00184.
- Background: PubMed 26507915Goobie SM. A blood transfusion can save a child's life or threaten it. Paediatr Anaesth. 2015 Dec;25(12):1182-3. doi: 10.1111/pan.12816. No abstract available.
- Background: PubMed 31934525Mikhail C, Pennington Z, Arnold PM, Brodke DS, Chapman JR, Chutkan N, Daubs MD, DeVine JG, Fehlings MG, Gelb DE, Ghobrial GM, Harrop JS, Hoelscher C, Jiang F, Knightly JJ, Kwon BK, Mroz TE, Nassr A, Riew KD, Sekhon LH, Smith JS, Traynelis VC, Wang JC, Weber MH, Wilson JR, Witiw CD, Sciubba DM, Cho SK. Minimizing Blood Loss in Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):71S-83S. doi: 10.1177/2192568219868475. Epub 2020 Jan 6.
- Background: PubMed 9298865Slaughter TF, Greenberg CS. Antifibrinolytic drugs and perioperative hemostasis. Am J Hematol. 1997 Sep;56(1):32-6. doi: 10.1002/(sici)1096-8652(199709)56:13.0.co;2-3.
- Individual participant dataSharing planned: Undecided
Related trials for Blood Loss, Surgical
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
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?
A study testing Tranexamic acid injection and Saline in people with Blood Loss, Surgical and Scoliosis, run by Cairo University.
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 4 inclusion and 3 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 10 Nov 2020. 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. Some participants in this study may receive a placebo. 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 Mina Adolf Helmy, MD (2001275716942, dr_mina20002010@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraperative blood loss in both groups (time frame: period of surgery(1-2 hours)). 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 NCT04622397, 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 10 Nov 2020.