Blood LossPhase 3BloodlossNCT05152186
Compare Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Blood Loss in Spine Surgeries
A Phase 3 study testing Topical Solution, Topical Foam and Topical in people with Blood Loss, run by Minia University at 1 site in Egypt.
Trial summary
To evaluate the effectiveness of topical TXA in reducing blood loss compared to H2O2 wash. The primary outcomes : 1. Estimation of Intraoperative blood loss and blood transfusion. 2. Recording Postoperative blood drainage. 3. Comparing Hemoglobin levels (pre and postoperative). The secondary outcomes : 1. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Blood Loss
- What is being tested?
- Topical Solution, Topical Foam and Topical
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 2021
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA: class II or III
- Sex: male and female
- Age: from 20 to 70 years.
- Type of operation: patient will undergo spinal surgery with a diagnosis of in place spinal trauma, thoracic or lumbar degenerative disease, such as spinal canal stenosis, disc herniation, spondylolisthesis, and/or degenerative scoliosis under general anesthesia.
Who cannot join
- Patients with history of thromboembolic disease or coagulopathy or hereditary bleeding disorders such as factor VIII deficiency, factor IX deficiency, and Von-Willebrand disease.
- Patients who were taking anticoagulants or antiplatelet drugs.
- Allergy or hypersensitivity to TXA.
- A dural tear accompanied by cerebrospinal fluid leakage detected intraoperatively.
- Spinal cord tumors, head trauma and penetrating spinal cord trauma.
- The use of intravenous TXA during the perioperative period .
- Infection at the operative site e.g T.B.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Perioperative Blood Loss in Elective Spine Surgeries
To evaluate the effectiveness of topical TXA in reducing blood loss compared to H2O2 wash.
The primary outcomes :
- Estimation of Intraoperative blood loss and blood transfusion.
- Recording Postoperative blood drainage.
- Comparing Hemoglobin levels (pre and postoperative).
The secondary outcomes :
- Surgical site infection (SSI)
- Length of hospital stay.
Read the detailed description
Spinal surgery is one of the most commonly performed neuro-surgeries worldwide. Massive blood loss occurs frequently and remains a challenge in complex spinal surgery. Significant intra and postoperative hemorrhage negatively affects patient outcomes by increasing coagulopathy, postoperative hematoma and anemia .The need for allogenic blood transfusions can lead to potential transfusion reactions and infections, in addition to increasing long-term mortality rates. There is an economic disadvantage associated with iatrogenic major blood loss relating to the direct costs of the blood products and intraoperative blood salvage technology and indirect costs of prolonged patient hospitalization and complication management .
Many efforts have focused on achieving better perioperative blood conservation, in particular through prophylactic intravenous administration of antifibrinolytic agents before and during major surgery. Intravenous administration of the inexpensive but highly effective drug as tranexamic acid (TXA) reduces perioperative hemorrhage and the need for blood transfusions by one third in major surgery, including spinal surgery, Included on the list of the World Health Organization (WHO) List of Essential Medicines, TXA has taken its place as a widely used hemostatic agent in the clinical setting .
Tranexamic acid is a synthetic analog of the amino acid lysine. It serves as an antifibrinolytic by reversibly binding four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, preventing fibrin degradation and preserving the framework of fibrin's matrix structure .Tranexamic acid has roughly eight times the antifibrinolytic activity of an older analogue, ε-aminocaproic acid. Tranexamic acid also directly inhibits the activity of plasmin with weak potency .
Hydrogen peroxide (H2O2) is an inexpensive and readily available option whose hemostatic and antiseptic properties have been separately confirmedin several previous studies .
- Conditions
- Blood Loss
- Being tested
- Topical Solution, Topical Foam, Topical
- Keywords
- Blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical SolutionDrug
Also called Irrigation
Topical administration
Topical FoamDrug
Also called Disinfectant
Topical administration
TopicalOther
Also called Crystalloid
Topical administration
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Active comparator | Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss Receives: Drug: Topical Solution; Drug: Topical Foam; Other: Topical |
| Hydrogen peroxide | Active comparator | Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss Receives: Drug: Topical Solution; Drug: Topical Foam; Other: Topical |
| Normal saline | Placebo comparator | Hemostasis in spine surgery Receives: Drug: Topical Solution; Drug: Topical Foam; Other: Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss estimation [NCT ID not yet assigned]
Estimation of perioperative blood loss and need of blood transfusion, lab investigations pre and postoperative (hemoglobin (gm/dL), hematocrit (%), Prothrombin concentration (%), INR, platelets).
- Recording Postoperative blood drainage (in ml). and Comparing Hemoglobin levels (pre and postoperative).
Measured: Within 48 hours
Secondary outcomes (1)
Complications
Anaemia secondary to blood loss, surgical site infection , length of hospital stay (in days), complications of drugs used in procedure.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jun 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Minia 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Kamal Mohamed, Minia University
- Investigators
- Amani Khairy, Professor, Study chair, Minia UniversitySarah Mohamed, Lecturer, Study director, Minia UniversityWalid Zidan, Lecturer, Study director, Minia UniversityNehal Kamal, Master, Principal investigator, Faulty of medicine, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152186
- Sponsor's protocol ID
- blood loss in spine surgery
- Acronym
- Bloodloss
- Status last verified
- Dec 2021
- First submitted
- 12 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qureshi R, Puvanesarajah V, Jain A, Hassanzadeh H. Perioperative Management of Blood Loss in Spine Surgery. Clin Spine Surg. 2017 Nov;30(9):383-388. doi: 10.1097/BSD.0000000000000532.
PubMed 28338491Hui S, Peng Y, Tao L, Wang S, Yang Y, Du Y, Zhang J, Zhuang Q; TARGETS study group. Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis. J Orthop Surg Res. 2021 Jun 22;16(1):401. doi: 10.1186/s13018-021-02548-6.
PubMed 34158096
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Perioperative Blood Loss in Elective Spine Surgeries
- ClinicalTrials.gov ID
- NCT05152186
- Acronym / sponsor ID
- Bloodloss / blood loss in spine surgery
- Conditions
- Blood Loss
- Keywords
- Blood loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Dec 2021 (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 evaluate the effectiveness of topical TXA in reducing blood loss compared to H2O2 wash.
The primary outcomes :
- Estimation of Intraoperative blood loss and blood transfusion.
- Recording Postoperative blood drainage.
- Comparing Hemoglobin levels (pre and postoperative).
The secondary outcomes :
- Surgical site infection (SSI)
- Length of hospital stay.
Detailed description
Spinal surgery is one of the most commonly performed neuro-surgeries worldwide. Massive blood loss occurs frequently and remains a challenge in complex spinal surgery. Significant intra and postoperative hemorrhage negatively affects patient outcomes by increasing coagulopathy, postoperative hematoma and anemia .The need for allogenic blood transfusions can lead to potential transfusion reactions and infections, in addition to increasing long-term mortality rates. There is an economic disadvantage associated with iatrogenic major blood loss relating to the direct costs of the blood products and intraoperative blood salvage technology and indirect costs of prolonged patient hospitalization and complication management .
Many efforts have focused on achieving better perioperative blood conservation, in particular through prophylactic intravenous administration of antifibrinolytic agents before and during major surgery. Intravenous administration of the inexpensive but highly effective drug as tranexamic acid (TXA) reduces perioperative hemorrhage and the need for blood transfusions by one third in major surgery, including spinal surgery, Included on the list of the World Health Organization (WHO) List of Essential Medicines, TXA has taken its place as a widely used hemostatic agent in the clinical setting .
Tranexamic acid is a synthetic analog of the amino acid lysine. It serves as an antifibrinolytic by reversibly binding four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, preventing fibrin degradation and preserving the framework of fibrin's matrix structure .Tranexamic acid has roughly eight times the antifibrinolytic activity of an older analogue, ε-aminocaproic acid. Tranexamic acid also directly inhibits the activity of plasmin with weak potency .
Hydrogen peroxide (H2O2) is an inexpensive and readily available option whose hemostatic and antiseptic properties have been separately confirmedin several previous studies .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Active comparator | Drug: Topical Solution, Drug: Topical Foam, Other: TopicalTopical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss |
| Hydrogen peroxide | Active comparator | Drug: Topical Solution, Drug: Topical Foam, Other: TopicalTopical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss |
| Normal saline | Placebo comparator | Drug: Topical Solution, Drug: Topical Foam, Other: TopicalHemostasis in spine surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA: class II or III
- Sex: male and female
- Age: from 20 to 70 years.
- Type of operation: patient will undergo spinal surgery with a diagnosis of in place spinal trauma, thoracic or lumbar degenerative disease, such as spinal canal stenosis, disc herniation, spondylolisthesis, and/or degenerative scoliosis under general anesthesia.
Key exclusion criteria (7 listed)
- Patients with history of thromboembolic disease or coagulopathy or hereditary bleeding disorders such as factor VIII deficiency, factor IX deficiency, and Von-Willebrand disease.
- Patients who were taking anticoagulants or antiplatelet drugs.
- Allergy or hypersensitivity to TXA.
- A dural tear accompanied by cerebrospinal fluid leakage detected intraoperatively.
- Spinal cord tumors, head trauma and penetrating spinal cord trauma.
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 |
|---|---|---|
| Topical SolutionAlso: IrrigationTopical administration | Drug | Hydrogen peroxide, Normal saline, tranexamic acid |
| Topical FoamAlso: DisinfectantTopical administration | Drug | Hydrogen peroxide, Normal saline, tranexamic acid |
| TopicalAlso: CrystalloidTopical administration | Other | Hydrogen peroxide, Normal saline, tranexamic acid |
Primary outcome
Blood loss estimation [NCT ID not yet assigned]
Time frame: Within 48 hours
Estimation of perioperative blood loss and need of blood transfusion, lab investigations pre and postoperative (hemoglobin (gm/dL), hematocrit (%), Prothrombin concentration (%), INR, platelets). * Recording Postoperative blood drainage (in ml). and Comparing Hemoglobin levels (pre and postoperative).
1 secondary outcome
Complications
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Background: PubMed 28338491Qureshi R, Puvanesarajah V, Jain A, Hassanzadeh H. Perioperative Management of Blood Loss in Spine Surgery. Clin Spine Surg. 2017 Nov;30(9):383-388. doi: 10.1097/BSD.0000000000000532.
- Background: PubMed 34158096Hui S, Peng Y, Tao L, Wang S, Yang Y, Du Y, Zhang J, Zhuang Q; TARGETS study group. Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis. J Orthop Surg Res. 2021 Jun 22;16(1):401. doi: 10.1186/s13018-021-02548-6.
- 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.
Amani Khairy, Professor study chair
Minia University
Sarah Mohamed, Lecturer study director
Minia University
Walid Zidan, Lecturer study director
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical Solution, Topical Foam and Topical in people with Blood Loss, run by Minia University at 1 site in Egypt.
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 7 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss estimation [NCT ID not yet assigned] (time frame: Within 48 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 NCT05152186, which also lists 2 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 9 Dec 2021.