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.
Anticoagulants
Gelatin sponge
Rectus sheath hematoma
Tranexamic acid
Journal
European journal of medical research
ISSN: 2047-783X
Titre abrégé: Eur J Med Res
Pays: England
ID NLM: 9517857
Informations de publication
Date de publication:
20 Oct 2023
20 Oct 2023
Historique:
received:
13
04
2023
accepted:
06
10
2023
medline:
1
11
2023
pubmed:
21
10
2023
entrez:
20
10
2023
Statut:
epublish
Résumé
This study aims to illustrate the impact of applying the tranexamic acid impregnated in a gelatin sponge between the anterior rectus sheath and the Rectus Abdominis muscle during Cesarean section (CS) in minimizing rectus sheath hematoma (RHS) in women treated with Warfarin. A clinical trial was carried out on 63 pregnant women attended for elective CS, who on antenatal warfarin anticoagulation started from 13 weeks gestation to 36 weeks then shifted to low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH), and with an indication for postnatal warfarin anticoagulation. They were randomly assigned on the day of the scheduled CS into three equal groups (21 women for each). Group 1 had two pieces of gelatin sponges soaked with one ampoule of tranexamic acid. Group 2 had two pieces of gelatin sponges not soaked with tranexamic acid. Group 3 (control group) had no gelatin sponge applied. All patients underwent postoperative assessment done for hemoglobin (Hb), hematocrit (HCT), estimated blood loss (EBL), amount and nature of discharge collected from the sub-rectus drain, complications (RHS, wound infection, thromboembolism), need for re-operation, and need for blood transfusion. Statistically significant differences were found between Group 1 and Group 2 regarding the postoperative Hb (10.66 ± 1.13 vs. 9.77 ± 0.69, P = 0.009), between Group 1 and Group 2 regarding the postoperative HCT (31.87 ± 3.59 vs. 28.54 ± 1.85, P = 0.001), between Group 1 and Group 2 regarding EBL (442.19 ± 244.46 vs. 744.38 ± 267.05, P = 0.003), between Group 1 and Group 3 regarding EBL (442.19 ± 244.46 vs. 664.29 ± 343.97, P = 0.040), and between Group 1 and Group 3 regarding the discharge amount from the sub rectus drain (190.48 ± 100.77 vs. 307.14 ± 127.76, P = 0.004). Tranexamic acid-soaked gelatin sponges are safe and effective in reducing postoperative drainage and EBL. At ClinicalTrials.gov in June 2022 (NCT05439694).
Sections du résumé
BACKGROUND
BACKGROUND
This study aims to illustrate the impact of applying the tranexamic acid impregnated in a gelatin sponge between the anterior rectus sheath and the Rectus Abdominis muscle during Cesarean section (CS) in minimizing rectus sheath hematoma (RHS) in women treated with Warfarin.
METHODS
METHODS
A clinical trial was carried out on 63 pregnant women attended for elective CS, who on antenatal warfarin anticoagulation started from 13 weeks gestation to 36 weeks then shifted to low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH), and with an indication for postnatal warfarin anticoagulation. They were randomly assigned on the day of the scheduled CS into three equal groups (21 women for each). Group 1 had two pieces of gelatin sponges soaked with one ampoule of tranexamic acid. Group 2 had two pieces of gelatin sponges not soaked with tranexamic acid. Group 3 (control group) had no gelatin sponge applied. All patients underwent postoperative assessment done for hemoglobin (Hb), hematocrit (HCT), estimated blood loss (EBL), amount and nature of discharge collected from the sub-rectus drain, complications (RHS, wound infection, thromboembolism), need for re-operation, and need for blood transfusion.
RESULTS
RESULTS
Statistically significant differences were found between Group 1 and Group 2 regarding the postoperative Hb (10.66 ± 1.13 vs. 9.77 ± 0.69, P = 0.009), between Group 1 and Group 2 regarding the postoperative HCT (31.87 ± 3.59 vs. 28.54 ± 1.85, P = 0.001), between Group 1 and Group 2 regarding EBL (442.19 ± 244.46 vs. 744.38 ± 267.05, P = 0.003), between Group 1 and Group 3 regarding EBL (442.19 ± 244.46 vs. 664.29 ± 343.97, P = 0.040), and between Group 1 and Group 3 regarding the discharge amount from the sub rectus drain (190.48 ± 100.77 vs. 307.14 ± 127.76, P = 0.004).
CONCLUSION
CONCLUSIONS
Tranexamic acid-soaked gelatin sponges are safe and effective in reducing postoperative drainage and EBL.
CLINICAL TRIAL REGISTRATION
BACKGROUND
At ClinicalTrials.gov in June 2022 (NCT05439694).
Identifiants
pubmed: 37864195
doi: 10.1186/s40001-023-01434-7
pii: 10.1186/s40001-023-01434-7
pmc: PMC10588007
doi:
Substances chimiques
Tranexamic Acid
6T84R30KC1
Gelatin
9000-70-8
Warfarin
5Q7ZVV76EI
Heparin
9005-49-6
Heparin, Low-Molecular-Weight
0
Anticoagulants
0
Banques de données
ClinicalTrials.gov
['NCT05439694']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
448Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
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