Rectus Sheath HematomaPhase 4NCT05439694
TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin
A Phase 4 study testing Tranexamic acid in people with Rectus Sheath Hematoma and Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this randomized controlled study is to demonstrate the effect of Local application of TXA impregnated in a gelatin sponge in reducing Rectus sheath hematoma formation in patients treated with warfarin following cesarean section. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rectus Sheath Hematoma, Cesarean Section
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2022to 1 Feb 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- o Pregnant women attending for elective CS.
- Women on antenatal anticoagulation ( LMWH , UFH , Fondaparinux ) for conditions such as : Prosthetic Valve , DVT , Pulmonary embolism , Dural sinus thrombosis , AF.
- Pregnant Women with indication for postnatal warfarin anticoagulation( Prosthetic Valve , DVT , Dural Sinus Thrombosis , AF , Pulmonary embolism )
- Age between 20-40 years.
- Pregnancies between 37 and 39 weeks
- BMI between (18.5 - 30.0)
Who cannot join
- o Pregnancy with risk of obstetric hemorrhage such as abnormally invasive placenta, placenta previa, placental abruption.
- Women with Renal and Hepatic failure
- Women with bleeding diathesis for reasons other than warfarin anticoagulation therapy
- Women with known allergy to Tranexamic acid
- Anemia Hb below 8g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Tranexamic Acid Soaked Absorbable Gelatin Sponge in Reducing Rectus Sheath Hematoma Formation After Cesarean Section in Patients Using Warfarin Compounds
The aim of this randomized controlled study is to demonstrate the effect of Local application of TXA impregnated in a gelatin sponge in reducing Rectus sheath hematoma formation in patients treated with warfarin following cesarean section.
Read the detailed description
The study will include (63) pregnant women attending for cesarean delivery who will receive anticoagulation (warfarin) postnatally.
Patients included in this study will be subjected to:
- Informed consent: patients representing the study population will be counselled about the intervention and informed written consent will be taken.
Consenting patients will be subjected to the following:
- Detailed personal, obstetric and medical and surgical history. 2- Examination: General Examination.
- Vital signs: Blood pressure, pulse and temperature.
- Weight, height, BMI.
- Abdominal examination for assessment of fundal level. 3. Laboratory Investigations Preoperatively
- CBC, Coagulation Profile, Blood Chemistry. 5. Abdominal Ultrasound: in order to assess the following: a. Gestational age determination. c. Placental site. CS will be done by Senior Obstetricians, Using Standard CS technique, with visceral and parietal peritoneum re-approximation and insertion of a passive intraperitoneal drain. Fascial closure will be done using continuous slowly absorbable sutures. Meticulous hemostasis will be achieved using monopolar cauterization. An active drain (Hemovac®) will be applied in the space between anterior rectus sheath and the rectus abdominis muscle in all patients.
Patients will be randomly assigned into three groups Randomization is done by computer generated random numbers in opaque envelops.
Group 1:
(21) patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle.
Group 2:
(21) patients will have 2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) Not impregnated with Tranexamic acid applied locally using the same method as the previous group.
Group 3:
(21) patients will have Neither Gelatin Sponge nor Tranexamic acid applied. Follow up patients for vital signs and manifestations of allergic reactions in the immediate post operative period.
The intraperitoneal drain will be removed after 24 hours in all groups. While the (Hemovac®) drain will be removed after achieving target INR in all groups.
All Patients will be receiving bridging anticoagulation using LMWH(Enoxaparin) alone for 3 days in therapeutic doses (1mg/kg twice daily) to be initiated 12 hours after Surgery in most cases.Then Warfarin will be added on post operative day 3. LMWH will be withdrawn after achieving target INR.
Then comparison between the three groups regarding
- Hemovac® Drain output in cc per day till achieving Target INR Levels for all patients.
- Ultrasound assessment of rectus sheath hematoma if present after achieving Target INR Levels for all patients.
- Conditions
- Rectus Sheath Hematoma, Cesarean Section
- Being tested
- Tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India)
have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
| Study group | Role | What they receive |
|---|---|---|
| Gelatin Sponges soaked with TXA | Experimental | 21 patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle. Receives: Drug: Tranexamic acid |
| Gelatin Sponges | Experimental | 2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) Receives: Drug: Tranexamic acid |
| NO SPONGE | No intervention | 21 patients will have no sponge inserted 10 ml of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectus sheath hematoma formation
Rectus sheath hematoma formation detected by Ultrasound
Measured: 1 weeks
Excessive bleeding from subrectus space
amount of blood coming out of the drains
Measured: 1 week
Secondary outcomes (3)
Thromboembolic manifestations
DVT
Measured: 1 weeks
Blood transfusion
ml
Measured: 1 week
The need for surgical evacuation of rectus sheath hematoma
surgery
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start3 Jul 2022
- Primary completion1 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rectus Sheath HematomaStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Hany, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439694
- Sponsor's protocol ID
- AymanMscPPH
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibbons L, Belizan JM, Lauer JA, Betran AP, Merialdi M, Althabe F. Inequities in the use of cesarean section deliveries in the world. Am J Obstet Gynecol. 2012 Apr;206(4):331.e1-19. doi: 10.1016/j.ajog.2012.02.026. Epub 2012 Mar 1.
PubMed 22464076Hatjipetrou A, Anyfantakis D, Kastanakis M. Rectus sheath hematoma: a review of the literature. Int J Surg. 2015 Jan;13:267-271. doi: 10.1016/j.ijsu.2014.12.015. Epub 2014 Dec 19.
PubMed 25529279Cherry WB, Mueller PS. Rectus sheath hematoma: review of 126 cases at a single institution. Medicine (Baltimore). 2006 Mar;85(2):105-110. doi: 10.1097/01.md.0000216818.13067.5a.
PubMed 16609349Jafferbhoy SF, Rustum Q, Shiwani MH. Abdominal compartment syndrome--a fatal complication from a rectus sheath haematoma. BMJ Case Rep. 2012 Apr 2;2012:bcr1220115332. doi: 10.1136/bcr.12.2011.5332.
PubMed 22602838Osinbowale O, Bartholomew JR. Rectus sheath hematoma. Vasc Med. 2008 Nov;13(4):275-9. doi: 10.1177/1358863X08094767.
PubMed 18940904McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.
PubMed 22397329Liang J, Liu H, Huang X, Xiong W, Zhao H, Chua S, Li Z. Using tranexamic acid soaked absorbable gelatin sponge following complex posterior lumbar spine surgery: A randomized control trial. Clin Neurol Neurosurg. 2016 Aug;147:110-4. doi: 10.1016/j.clineuro.2016.06.001. Epub 2016 Jun 13.
PubMed 27343711Hany A, Mansour A, Sediek M, Nabil M. Role of tranexamic acid-soaked gelatin sponge in minimizing rectus sheath hematoma after cesarean section in women treated with warfarin, a simple tool for high-risk cases, a randomized controlled trial. Eur J Med Res. 2023 Oct 20;28(1):448. doi: 10.1186/s40001-023-01434-7.
PubMed 37864195
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Tranexamic Acid Soaked Absorbable Gelatin Sponge in Reducing Rectus Sheath Hematoma Formation After Cesarean Section in Patients Using Warfarin Compounds
- ClinicalTrials.gov ID
- NCT05439694
- Acronym / sponsor ID
- AymanMscPPH
- Conditions
- Rectus Sheath Hematoma, Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 30 Jun 2022 (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.
The aim of this randomized controlled study is to demonstrate the effect of Local application of TXA impregnated in a gelatin sponge in reducing Rectus sheath hematoma formation in patients treated with warfarin following cesarean section.
Detailed description
The study will include (63) pregnant women attending for cesarean delivery who will receive anticoagulation (warfarin) postnatally.
Patients included in this study will be subjected to:
- Informed consent: patients representing the study population will be counselled about the intervention and informed written consent will be taken.
Consenting patients will be subjected to the following:
- Detailed personal, obstetric and medical and surgical history. 2- Examination: General Examination.
- Vital signs: Blood pressure, pulse and temperature.
- Weight, height, BMI.
- Abdominal examination for assessment of fundal level. 3. Laboratory Investigations Preoperatively
- CBC, Coagulation Profile, Blood Chemistry. 5. Abdominal Ultrasound: in order to assess the following: a. Gestational age determination. c. Placental site. CS will be done by Senior Obstetricians, Using Standard CS technique, with visceral and parietal peritoneum re-approximation and insertion of a passive intraperitoneal drain. Fascial closure will be done using continuous slowly absorbable sutures. Meticulous hemostasis will be achieved using monopolar cauterization. An active drain (Hemovac®) will be applied in the space between anterior rectus sheath and the rectus abdominis muscle in all patients.
Patients will be randomly assigned into three groups Randomization is done by computer generated random numbers in opaque envelops.
Group 1:
(21) patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle.
Group 2:
(21) patients will have 2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) Not impregnated with Tranexamic acid applied locally using the same method as the previous group.
Group 3:
(21) patients will have Neither Gelatin Sponge nor Tranexamic acid applied. Follow up patients for vital signs and manifestations of allergic reactions in the immediate post operative period.
The intraperitoneal drain will be removed after 24 hours in all groups. While the (Hemovac®) drain will be removed after achieving target INR in all groups.
All Patients will be receiving bridging anticoagulation using LMWH(Enoxaparin) alone for 3 days in therapeutic doses (1mg/kg twice daily) to be initiated 12 hours after Surgery in most cases.Then Warfarin will be added on post operative day 3. LMWH will be withdrawn after achieving target INR.
Then comparison between the three groups regarding
- Hemovac® Drain output in cc per day till achieving Target INR Levels for all patients.
- Ultrasound assessment of rectus sheath hematoma if present after achieving Target INR Levels for all patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gelatin Sponges soaked with TXA | Experimental | Drug: Tranexamic acid21 patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle. |
| Gelatin Sponges | Experimental | Drug: Tranexamic acid2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) |
| NO SPONGE | No intervention | –21 patients will have no sponge inserted 10 ml of saline |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- o Pregnant women attending for elective CS.
Key exclusion criteria (5 listed)
- o Pregnancy with risk of obstetric hemorrhage such as abnormally invasive placenta, placenta previa, placental abruption.
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: Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India)have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) | Drug | Gelatin Sponges, Gelatin Sponges soaked with TXA |
Primary outcome
Rectus sheath hematoma formation
Time frame: 1 weeks
Rectus sheath hematoma formation detected by Ultrasound
Excessive bleeding from subrectus space
Time frame: 1 week
amount of blood coming out of the drains
3 secondary outcomes
Thromboembolic manifestations
Time frame: 1 weeks
Blood transfusion
Time frame: 1 week
The need for surgical evacuation of rectus sheath hematoma
Time frame: 1 week
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 Feb 2023.
- Background: PubMed 22464076Gibbons L, Belizan JM, Lauer JA, Betran AP, Merialdi M, Althabe F. Inequities in the use of cesarean section deliveries in the world. Am J Obstet Gynecol. 2012 Apr;206(4):331.e1-19. doi: 10.1016/j.ajog.2012.02.026. Epub 2012 Mar 1.
- Background: PubMed 25529279Hatjipetrou A, Anyfantakis D, Kastanakis M. Rectus sheath hematoma: a review of the literature. Int J Surg. 2015 Jan;13:267-271. doi: 10.1016/j.ijsu.2014.12.015. Epub 2014 Dec 19.
- Background: PubMed 16609349Cherry WB, Mueller PS. Rectus sheath hematoma: review of 126 cases at a single institution. Medicine (Baltimore). 2006 Mar;85(2):105-110. doi: 10.1097/01.md.0000216818.13067.5a.
- Background: PubMed 22602838Jafferbhoy SF, Rustum Q, Shiwani MH. Abdominal compartment syndrome--a fatal complication from a rectus sheath haematoma. BMJ Case Rep. 2012 Apr 2;2012:bcr1220115332. doi: 10.1136/bcr.12.2011.5332.
- Background: PubMed 18940904Osinbowale O, Bartholomew JR. Rectus sheath hematoma. Vasc Med. 2008 Nov;13(4):275-9. doi: 10.1177/1358863X08094767.
- Background: PubMed 22397329McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.
- Background: PubMed 27343711Liang J, Liu H, Huang X, Xiong W, Zhao H, Chua S, Li Z. Using tranexamic acid soaked absorbable gelatin sponge following complex posterior lumbar spine surgery: A randomized control trial. Clin Neurol Neurosurg. 2016 Aug;147:110-4. doi: 10.1016/j.clineuro.2016.06.001. Epub 2016 Jun 13.
- Derived from this study: PubMed 37864195Hany A, Mansour A, Sediek M, Nabil M. Role of tranexamic acid-soaked gelatin sponge in minimizing rectus sheath hematoma after cesarean section in women treated with warfarin, a simple tool for high-risk cases, a randomized controlled trial. Eur J Med Res. 2023 Oct 20;28(1):448. doi: 10.1186/s40001-023-01434-7.
- Individual participant dataSharing planned: No
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.
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 in people with Rectus Sheath Hematoma and Cesarean Section, run by Cairo 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 6 inclusion and 5 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 Feb 2023. 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. 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?
Rectus sheath hematoma formation (time frame: 1 weeks). The study lists 2 primary outcomes in all. 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 NCT05439694, which also lists 8 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 21 Feb 2023.