BleedingNCT06453772
How to Predict Post-Surgical Bleeding and Hemoglobin in Liposuction?
An observational study of Bleeding and Surgery, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.
Trial summary
To evaluate the effect of using a mathematical model developed through pre- and post-surgical hemoglobins to predict the volume to aspirate in patients undergoing primary body liposuction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Liposuction
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Jan 2022to 1 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing the first-time liposuction procedure, operated in the Plastic and Reconstructive Surgery Service
Who may be able to join
- Patients of indistinct gender, operated on at the Centro Médico Nacional de Occidente for primary liposuction.
- Age between 18 to 60 years old
- Liposuction technique used: Super wet or Tumescent.
- Surgical procedure on any area of the body
- Large volume liposuction (> 5 L)
- Use of regional anesthesia
Who cannot join
- Presence of any of the following comorbidities: Systemic Arterial Hypertension or Diabetes Mellitus type 2.
- Performance of 2 or more procedures
- Use of medications (NSAIDs and/or coadjuvants that modify coagulation times).
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
National Western Speciality Hospital, Mexican Social Security Institute
Guadalajara, Jalisco, 44329
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Using a Mathematical Model Based on pre-and Post-surgical Hemoglobin Differences to Determine the Volume to Aspirate in Primary Body Liposuction.
To evaluate the effect of using a mathematical model developed through pre- and post-surgical hemoglobins to predict the volume to aspirate in patients undergoing primary body liposuction.
Read the detailed description
Postoperative anemia is a significant risk associated with liposuction, yet the scientific literature lacks detailed data on blood loss relative to the volume of fat removed. To address this, the investigators aimed to develop a mathematical formula predicting the decrease in postoperative hemoglobin (Hb post) based on preoperative hemoglobin (Hb pre), Body Mass Index (BMI), and the volume of fat suctioned. An observational, analytical, non-experimental, prospective study was conducted on liposuction patients to validate this predictive formula. Statistical analysis using Spearman's test showed that the results were statistically significant (P < 0.05).
- Being tested
- Liposuction
- Keywords
- bleeding, abdominoplasty, Liposuction, Hemoglobin
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
Primary or secondary liposuction is performed by the surgical staff. The study analyzed variables including weight, height, BMI, preoperative hemoglobin, and aspirated volume. Additionally, preoperative hemoglobin (Hb), hematocrit (Hto), platelets, prothrombin time (Tp), partial prothrombin time (TpT), and International Normalized Ratio (INR) were evaluated. Hb and Hto levels were reassessed 24 hours post-surgery to monitor changes.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing liposuction | Not described Receives: Procedure: Liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Predicting Method
Mathematical model based on pre-and post-surgical hemoglobins to further predict estimated bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Clotilde Fuentes-Orozco, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453772
- Sponsor's protocol ID
- LIPOSUCTION-24
- Status last verified
- May 2025
- First submitted
- 30 May 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using a Mathematical Model Based on pre-and Post-surgical Hemoglobin Differences to Determine the Volume to Aspirate in Primary Body Liposuction.
- ClinicalTrials.gov ID
- NCT06453772
- Acronym / sponsor ID
- LIPOSUCTION-24
- Keywords
- bleeding, abdominoplasty, Liposuction, Hemoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Jun 2024 (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 effect of using a mathematical model developed through pre- and post-surgical hemoglobins to predict the volume to aspirate in patients undergoing primary body liposuction.
Detailed description
Postoperative anemia is a significant risk associated with liposuction, yet the scientific literature lacks detailed data on blood loss relative to the volume of fat removed. To address this, the investigators aimed to develop a mathematical formula predicting the decrease in postoperative hemoglobin (Hb post) based on preoperative hemoglobin (Hb pre), Body Mass Index (BMI), and the volume of fat suctioned. An observational, analytical, non-experimental, prospective study was conducted on liposuction patients to validate this predictive formula. Statistical analysis using Spearman's test showed that the results were statistically significant (P < 0.05).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing liposuction | – | Procedure: Liposuction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing the first-time liposuction procedure, operated in the Plastic and Reconstructive Surgery Service
Key inclusion criteria (6 listed)
- Patients of indistinct gender, operated on at the Centro Médico Nacional de Occidente for primary liposuction.
- Age between 18 to 60 years old
- Liposuction technique used: Super wet or Tumescent.
- Surgical procedure on any area of the body
- Large volume liposuction (> 5 L)
Key exclusion criteria (3 listed)
- Presence of any of the following comorbidities: Systemic Arterial Hypertension or Diabetes Mellitus type 2.
- Performance of 2 or more procedures
- Use of medications (NSAIDs and/or coadjuvants that modify coagulation times).
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 |
|---|---|---|
| LiposuctionPrimary or secondary liposuction is performed by the surgical staff. The study analyzed variables including weight, height, BMI, preoperative hemoglobin, and aspirated volume. Additionally, preoperative hemoglobin (Hb), hematocrit (Hto), platelets, prothrombin time (Tp), partial prothrombin time (TpT), and International Normalized Ratio (INR) were evaluated. Hb and Hto levels were reassessed 24 hours post-surgery to monitor changes. | Procedure or surgery | Patients undergoing liposuction |
Primary outcome
Bleeding Predicting Method
Time frame: 12 months
Mathematical model based on pre-and post-surgical hemoglobins to further predict estimated bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Surgery, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.
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 6 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bleeding Predicting Method (time frame: 12 months). 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 4 Jun 2025.