TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin
The Effect of Using Tranexamic Acid Soaked Absorbable Gelatin Sponge in Reducing Rectus Sheath Hematoma Formation After Cesarean Section in Patients Using Warfarin Compounds
1 other identifier
interventional
63
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
July 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFebruary 21, 2023
February 1, 2023
6 months
June 22, 2022
February 17, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Rectus sheath hematoma formation
Rectus sheath hematoma formation detected by Ultrasound
1 weeks
Excessive bleeding from subrectus space
amount of blood coming out of the drains
1 week
Secondary Outcomes (3)
Thromboembolic manifestations
1 weeks
Blood transfusion
1 week
The need for surgical evacuation of rectus sheath hematoma
1 week
Study Arms (3)
Gelatin Sponges soaked with TXA
EXPERIMENTAL21 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
EXPERIMENTAL2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2)
NO SPONGE
NO INTERVENTION21 patients will have no sponge inserted 10 ml of saline
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (8)
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.
PMID: 22464076BACKGROUNDHatjipetrou 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.
PMID: 25529279BACKGROUNDCherry 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.
PMID: 16609349BACKGROUNDJafferbhoy 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.
PMID: 22602838BACKGROUNDOsinbowale O, Bartholomew JR. Rectus sheath hematoma. Vasc Med. 2008 Nov;13(4):275-9. doi: 10.1177/1358863X08094767.
PMID: 18940904BACKGROUNDMcCormack 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.
PMID: 22397329BACKGROUNDLiang 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.
PMID: 27343711BACKGROUNDHany 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.
PMID: 37864195DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 30, 2022
Study Start
July 3, 2022
Primary Completion
January 1, 2023
Study Completion
February 1, 2023
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share