Post Partum HemorrhagePhase 4NCT01599468
Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery
A Phase 4 study testing Tranexamic Acid and saline serum in people with Post Partum Hemorrhage, run by Hédi Chaker Hospital at 1 site in Tunisia.
Trial summary
The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery. This was a randomised, placebo controlled trial including 74 patients. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Tranexamic Acid and saline serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2011to Apr 2012
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA1 parturients
- aged from 20 to 40
- correct preoperative haemostatic status (prothrombine ratio > 60 % and platelet rate > 100 000),
- cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone
Who cannot join
- abnormal placentation
- severe pre-eclampsia
- coagulopathy and uterine rupture
- the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care
Sfax, Sfax Governorate, 3029
About this study
Official title: Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.
The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.
This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Tranexamic Acid, saline serum
- Keywords
- post partum hemorrhage, transfusion, tranexamic acid
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called exacyl
10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours
saline serumDrug
Also called normal saline; NaCl 0.9%
The Placebo group received normal saline with the same volumes
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid, post partum hemorrhage | Experimental | Not described Receives: Drug: Tranexamic Acid |
| placebo | Placebo comparator | Not described Receives: Drug: saline serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume blood loss
Measured: within 5 days after delivery
Secondary outcomes (1)
transfusion rates.
Measured: within 5 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum HemorrhageStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hédi Chaker Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed ayedi, Hédi Chaker Hospital
- Investigators
- mohamed ayedi, Principal investigator, hedi chaker university hospital of sfax, tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599468
- Sponsor's protocol ID
- TXA-1
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group; Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.
PubMed 21496253
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT01599468
- Acronym / sponsor ID
- TXA-1
- Conditions
- Post Partum Hemorrhage
- Keywords
- post partum hemorrhage, transfusion, tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hédi Chaker HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 May 2012 (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.
The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.
This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid, post partum hemorrhage | Experimental | Drug: Tranexamic Acid |
| placebo | Placebo comparator | Drug: saline serum |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA1 parturients
- aged from 20 to 40
- correct preoperative haemostatic status (prothrombine ratio > 60 % and platelet rate > 100 000),
- cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone
Key exclusion criteria (4 listed)
- abnormal placentation
- severe pre-eclampsia
- coagulopathy and uterine rupture
- the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.
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: exacyl10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours | Drug | tranexamic acid, post partum hemorrhage |
| saline serumAlso: normal saline; NaCl 0.9%The Placebo group received normal saline with the same volumes | Drug | placebo |
Primary outcome
volume blood loss
Time frame: within 5 days after delivery
1 secondary outcome
transfusion rates.
Time frame: within 5 days after delivery
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 22 May 2012.
- Background: PubMed 21496253Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group; Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.
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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.
mohamed ayedi principal investigator
hedi chaker university hospital of sfax, tunisia
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 and saline serum in people with Post Partum Hemorrhage, run by Hédi Chaker Hospital at 1 site in Tunisia.
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 4 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 22 May 2012. 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 Tunisia. 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?
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?
volume blood loss (time frame: within 5 days after delivery). 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 NCT01599468, which also lists 1 linked publication.
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 22 May 2012.