BleedingPhase 4NCT03970213
Intravenous Tranexamic Acid During Rhytidectomy
A Phase 4 study testing Tranexamic Acid 100Mg/Ml Inj Vil 10Ml and Normal Saline 0.9% Infusion Solution Bag in people with Bleeding and Bruising Face, run by Glasgold Group Plastic Surgery at 1 site in United States.
Trial summary
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleeding, Bruising Face, Swelling Lips & Face
- What is being tested?
- Tranexamic Acid 100Mg/Ml Inj Vil 10Ml and Normal Saline 0.9% Infusion Solution Bag
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 30 Aug 2019
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery
Who cannot join
- History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference
Trial locations and contacts
1 site in 1 country.
United States1 site
Glasgold Group Plastic Surgery
Princeton, New Jersey, 08540
Mark J Glasgold, MD, 732-846-6540, mglasgold@gmail.com
Robert A Glasgold, MD
About this study
Official title: Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.
Read the detailed description
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
- Conditions
- Bleeding, Bruising Face, Swelling Lips & Face
- Being tested
- Tranexamic Acid 100Mg/Ml Inj Vil 10Ml, Normal Saline 0.9% Infusion Solution Bag
- Keywords
- Tranexamic acid, Rhytidectomy, Facelift
- Medical subject headings
- Hemorrhage, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 100Mg/Ml Inj Vil 10MlDrug
IV TXA given during surgery
Normal Saline 0.9% Infusion Solution BagDrug
IV saline given during surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later Receives: Drug: Normal Saline 0.9% Infusion Solution Bag |
| TXA Group | Experimental | One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later Receives: Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding
Subjective measure of intraoperative blood loss (mild, moderate, or severe)
Measured: Surgical time
Postoperative ecchymosis
Subjective measure of bruising rated as mild, moderate, or severe
Measured: Postoperative day 1
Postoperative ecchymosis
Subjective measure of bruising rated as mild, moderate, or severe
Measured: Postoperative day 6
Postoperative ecchymosis
Subjective measure of bruising rated as mild, moderate, or severe
Measured: Postoperative day 9
Postoperative edema
Subjective measure of swelling rated as mild, moderate, or severe
Measured: Postoperative day 1
Postoperative edema
Subjective measure of swelling rated as mild, moderate, or severe
Measured: Postoperative day 6
Postoperative edema
Subjective measure of swelling rated as mild, moderate, or severe
Measured: Postoperative day 9
Secondary outcomes (2)
Postoperative hematoma/seroma
Documentation of any postoperative collections seen during the first 10 days following surgery
Measured: 10 days postoperative
Complications
Documentation of any surgical or postoperative complications
Measured: 10 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start30 May 2019 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glasgold Group Plastic Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark J Glasgold, MD, Study director, Glasgold Group Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970213
- Sponsor's protocol ID
- GGPS19-01
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient demographics, surgical procedure performed, primary and secondary outcomes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study
- ClinicalTrials.gov ID
- NCT03970213
- Acronym / sponsor ID
- GGPS19-01
- Conditions
- Bleeding, Bruising Face, Swelling Lips & Face
- Keywords
- Tranexamic acid, Rhytidectomy, Facelift
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Glasgold Group Plastic SurgeryUniversity, hospital or other
- Study start
- 30 May 2019 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 31 May 2019 (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.
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.
Detailed description
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Normal Saline 0.9% Infusion Solution BagIntravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later |
| TXA Group | Experimental | Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10MlOne gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery
Key exclusion criteria (1 listed)
- History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference
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 100Mg/Ml Inj Vil 10MlIV TXA given during surgery | Drug | TXA Group |
| Normal Saline 0.9% Infusion Solution BagIV saline given during surgery | Drug | Control Group |
Primary outcome
Intraoperative bleeding
Time frame: Surgical time
Subjective measure of intraoperative blood loss (mild, moderate, or severe)
Postoperative ecchymosis
Time frame: Postoperative day 1
Subjective measure of bruising rated as mild, moderate, or severe
Postoperative ecchymosis
Time frame: Postoperative day 6
Subjective measure of bruising rated as mild, moderate, or severe
Postoperative ecchymosis
Time frame: Postoperative day 9
Subjective measure of bruising rated as mild, moderate, or severe
Postoperative edema
Time frame: Postoperative day 1
Subjective measure of swelling rated as mild, moderate, or severe
Postoperative edema
Time frame: Postoperative day 6
Subjective measure of swelling rated as mild, moderate, or severe
Postoperative edema
Time frame: Postoperative day 9
Subjective measure of swelling rated as mild, moderate, or severe
2 secondary outcomes
Postoperative hematoma/seroma
Time frame: 10 days postoperative
Complications
Time frame: 10 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: Yes. Patient demographics, surgical procedure performed, primary and secondary outcomes
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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.
Mark J Glasgold, MD study director
Glasgold Group Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid 100Mg/Ml Inj Vil 10Ml and Normal Saline 0.9% Infusion Solution Bag in people with Bleeding and Bruising Face, run by Glasgold Group Plastic Surgery at 1 site in United States.
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 1 inclusion and 1 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 31 May 2019. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Mark J Glasgold, MD (732-846-6540, mglasgold@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative bleeding (time frame: Surgical time). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2019.