Cleft PalatePhase 4NCT02422056
Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty
A Phase 4 study testing Tranexamic Acid and Saline in people with Cleft Palate and Hemorrhage, run by Professor Fernando Figueira Integral Medicine Institute.
Trial summary
Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Cleft Palate, Hemorrhage
- What is being tested?
- Tranexamic Acid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Mar 2015
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital
Who cannot join
- Preoperative hemoglobin lower than 10 mg / dl or platelet count less than 100,000 / mm3 ;
- Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
- History of bleeding disorders in first-degree relatives;
- Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
- Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
- Known allergy to tranexamic acid.
About this study
Official title: Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty : Randomized Study
Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.
Read the detailed description
Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10mg / kg bolus followed by continuous infusion of 1 mg / kg / h until the end of the procedure and patients receiving placebo in similar arrangements.
Besides the impact on the volume of intraoperative bleeding the incidence of postoperative wound dehiscence in the first week and the incidence of oronasal fistulas after 1 month were evaluated.
- Conditions
- Cleft Palate, Hemorrhage
- Being tested
- Tranexamic Acid, Saline
- Keywords
- Cleft Palate, Hemorrhage, Palatoplasty
- Medical subject headings
- Cleft Palate, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Transamin
Tranexamic acid bolus of 10 mg / kg at the beginning of palatoplasty, followed by infusion of 1 mg / kg / h until the end of the procedure
SalineDrug
Also called Control
Infusion of saline in the same rate used for the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline infusion: Group receiving saline as placebo during the surgical procedure Receives: Drug: Saline |
| Intervention | Experimental | Tranexamic acid infusion: Group that received a Tranexamic acid bolus of 10mg / kg, followed by continuous infusion of 1 mg / kg / hr until the end of the procedure. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative bleeding
Intraoperative bleeding volume defined as the sum of the volume of aspirated blood during the procedure and the volume of blood retained in the used gauze. The volume retained in the gauze was estimated by the difference between the dry weight and the weight after using them.
Measured: during surgery
Secondary outcomes (3)
Incidence of wound dehiscence
Presence of dehiscence of the surgical wound in partial or total plan of any extension, verified by clinical examination in the first postoperative return and photographic record. The existence of dehiscence was observed by the break in the suture line or extensive presence of fibrin in the wound bed (indicating open area at its base).
Measured: 5 days
Oronasal fistulas
Presence of oronasal fistula type II, III or IV in pittsburgh classification verified on postoperative return at 1 month and photographic record.
Measured: 1 month
incidence of significant bleeding complications
Incidence of bleeding requiring surgical intervention, blood transfusion or use of antifibrinolytic drugs in the postoperative period
Measured: During hospital stay, an expected average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Campelo Arantes, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- Guilherme C Arantes, Principal investigator, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422056
- Sponsor's protocol ID
- U1111-1167-4683
- Status last verified
- Apr 2015
- First submitted
- 31 Mar 2015
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty : Randomized Study
- ClinicalTrials.gov ID
- NCT02422056
- Acronym / sponsor ID
- U1111-1167-4683
- Conditions
- Cleft Palate, Hemorrhage
- Keywords
- Cleft Palate, Hemorrhage, Palatoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Apr 2015 (estimated)
- 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.
Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.
Detailed description
Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10mg / kg bolus followed by continuous infusion of 1 mg / kg / h until the end of the procedure and patients receiving placebo in similar arrangements.
Besides the impact on the volume of intraoperative bleeding the incidence of postoperative wound dehiscence in the first week and the incidence of oronasal fistulas after 1 month were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineSaline infusion: Group receiving saline as placebo during the surgical procedure |
| Intervention | Experimental | Drug: Tranexamic AcidTranexamic acid infusion: Group that received a Tranexamic acid bolus of 10mg / kg, followed by continuous infusion of 1 mg / kg / hr until the end of the procedure. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital
Key exclusion criteria (6 listed)
- Preoperative hemoglobin lower than 10 mg / dl or platelet count less than 100,000 / mm3 ;
- Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
- History of bleeding disorders in first-degree relatives;
- Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
- Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
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 AcidAlso: TransaminTranexamic acid bolus of 10 mg / kg at the beginning of palatoplasty, followed by infusion of 1 mg / kg / h until the end of the procedure | Drug | Intervention |
| SalineAlso: ControlInfusion of saline in the same rate used for the intervention group | Drug | Placebo |
Primary outcome
intraoperative bleeding
Time frame: during surgery
Intraoperative bleeding volume defined as the sum of the volume of aspirated blood during the procedure and the volume of blood retained in the used gauze. The volume retained in the gauze was estimated by the difference between the dry weight and the weight after using them.
3 secondary outcomes
Incidence of wound dehiscence
Time frame: 5 days
Oronasal fistulas
Time frame: 1 month
incidence of significant bleeding complications
Time frame: During hospital stay, an expected average of 2 days
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 21 Apr 2015.
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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.
Guilherme C Arantes principal investigator
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid and Saline in people with Cleft Palate and Hemorrhage, run by Professor Fernando Figueira Integral Medicine Institute.
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 6 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 21 Apr 2015. 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.
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?
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?
intraoperative bleeding (time frame: during surgery). 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 21 Apr 2015.