Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT05439694
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-26', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rectus sheath hematoma formation', 'timeFrame': '1 weeks', 'description': 'Rectus sheath hematoma formation detected by Ultrasound'}, {'measure': 'Excessive bleeding from subrectus space', 'timeFrame': '1 week', 'description': 'amount of blood coming out of the drains'}], 'secondaryOutcomes': [{'measure': 'Thromboembolic manifestations', 'timeFrame': '1 weeks', 'description': 'DVT'}, {'measure': 'Blood transfusion', 'timeFrame': '1 week', 'description': 'ml'}, {'measure': 'The need for surgical evacuation of rectus sheath hematoma', 'timeFrame': '1 week', 'description': 'surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectus Sheath Hematoma', 'Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '22464076', 'type': 'BACKGROUND', 'citation': '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': '25529279', 'type': 'BACKGROUND', 'citation': 'Hatjipetrou 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': '16609349', 'type': 'BACKGROUND', 'citation': 'Cherry 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': '22602838', 'type': 'BACKGROUND', 'citation': 'Jafferbhoy 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': '18940904', 'type': 'BACKGROUND', 'citation': 'Osinbowale O, Bartholomew JR. Rectus sheath hematoma. Vasc Med. 2008 Nov;13(4):275-9. doi: 10.1177/1358863X08094767.'}, {'pmid': '22397329', 'type': 'BACKGROUND', 'citation': 'McCormack 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': '27343711', 'type': 'BACKGROUND', 'citation': 'Liang 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': '37864195', 'type': 'DERIVED', 'citation': 'Hany 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study will include (63) pregnant women attending for cesarean delivery who will receive anticoagulation (warfarin) postnatally.\n\nPatients included in this study will be subjected to:\n\n\\- Informed consent: patients representing the study population will be counselled about the intervention and informed written consent will be taken.\n\nConsenting patients will be subjected to the following:\n\n1\\. Detailed personal, obstetric and medical and surgical history. 2- Examination: General Examination.\n\n* Vital signs: Blood pressure, pulse and temperature.\n* Weight, height, BMI.\n* Abdominal examination for assessment of fundal level. 3. Laboratory Investigations Preoperatively\n* 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.\n\nPatients will be randomly assigned into three groups Randomization is done by computer generated random numbers in opaque envelops.\n\nGroup 1:\n\n(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.\n\nGroup 2:\n\n(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.\n\nGroup 3:\n\n(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.\n\nThe 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.\n\nAll 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.\n\nThen comparison between the three groups regarding\n\n* Hemovac® Drain output in cc per day till achieving Target INR Levels for all patients.\n* Ultrasound assessment of rectus sheath hematoma if present after achieving Target INR Levels for all patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* o Pregnant women attending for elective CS.\n\n * Women on antenatal anticoagulation ( LMWH , UFH , Fondaparinux ) for conditions such as : Prosthetic Valve , DVT , Pulmonary embolism , Dural sinus thrombosis , AF.\n * Pregnant Women with indication for postnatal warfarin anticoagulation( Prosthetic Valve , DVT , Dural Sinus Thrombosis , AF , Pulmonary embolism )\n * Age between 20-40 years.\n * Pregnancies between 37 and 39 weeks\n * BMI between (18.5 - 30.0)\n\nExclusion Criteria:\n\n* o Pregnancy with risk of obstetric hemorrhage such as abnormally invasive placenta, placenta previa, placental abruption.\n\n * Women with Renal and Hepatic failure\n * Women with bleeding diathesis for reasons other than warfarin anticoagulation therapy\n * Women with known allergy to Tranexamic acid\n * Anemia Hb below 8g/dl'}, 'identificationModule': {'nctId': 'NCT05439694', 'briefTitle': 'TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of Using Tranexamic Acid Soaked Absorbable Gelatin Sponge in Reducing Rectus Sheath Hematoma Formation After Cesarean Section in Patients Using Warfarin Compounds', 'orgStudyIdInfo': {'id': 'AymanMscPPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gelatin Sponges soaked with TXA', 'description': '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.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Gelatin Sponges', 'description': '2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2)', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'NO_INTERVENTION', 'label': 'NO SPONGE', 'description': '21 patients will have no sponge inserted 10 ml of saline'}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India)'], 'description': '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)', 'armGroupLabels': ['Gelatin Sponges', 'Gelatin Sponges soaked with TXA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ayman Hany, MD', 'investigatorAffiliation': 'Cairo University'}}}}