TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin

February 17, 2023 updated by: Ayman Hany, MD, Cairo University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

1. 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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gelatin Sponges soaked with TXA
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.
Drug: Tranexamic acid
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)
Other Names:
  • Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India)
Experimental: Gelatin Sponges
2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2)
Drug: Tranexamic acid
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)
Other Names:
  • Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India)
No Intervention: NO SPONGE
21 patients will have no sponge inserted 10 ml of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rectus sheath hematoma formation
Time Frame: 1 weeks
Rectus sheath hematoma formation detected by Ultrasound
1 weeks
Excessive bleeding from subrectus space
Time Frame: 1 week
amount of blood coming out of the drains
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboembolic manifestations
Time Frame: 1 weeks
DVT
1 weeks
Blood transfusion
Time Frame: 1 week
ml
1 week
The need for surgical evacuation of rectus sheath hematoma
Time Frame: 1 week
surgery
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 26, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AymanMscPPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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