Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation

NCT05550623 | Active Not Recruiting

• 1 other identifier: 2202766
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Lower extremity amputation patients represent a frail group of patients with extensive comorbidity. The most common indication of amputation is ischemia, infection and concomitant ischemic pain due to underlying chronic disease, especially arteriosclerosis and diabetes. Prolonged general anesthesia and surgery as well as increased blood loss may result in impaired patient safety. Previous studies have shown total blood loss approx. 1000 mL in transfemoral amputations (TFA). Substantial blood loss during surgery increases the risk of anemic complications and death for this already weakened patient group. The aim of this randomized controlled trial is to improve patient safety by exploring the possibility of a more precautious surgical procedure for TFA. Hence, investigating the total blood loss and secondary differences in complications after TFA between patients operated with use of pneumatic tourniquet versus no tourniquet. Total blood loss is calculated via Nadlers approach. From a pilot series, sample size was calculated to 124, allocated 1:1 in two groups of 62 participants, to ensure detection of at least 200 mL difference in total blood loss. The hypothesis is that use of tourniquet will decrease the total blood loss, the amount of blood transfusions, time of surgery and complications related to postoperative anemia without a higher rate of adverse events. The secondary and explorative outcomes are blood transfusions, intraoperative blood loss, length of stay, time of surgery, risk of readmission, risk of re-operation, risk of mortality, complications during admission, quality of life (QoL), prosthesis use and the prosthesis-specific survey Prothesis Evaluation Questionnaire (PEQ). QoL is measured with the validated questionnaire EQ-5D-5L preoperatively, and at 3, 6, and 12 months postoperatively. The possibility to enhance patient safety is highly relevant, and this trial will aid in establishing evidence-based guidelines for TFA surgery.

Conditions

Amputation; Blood Loss

Keywords

Tourniquet; Major Lower Extremity Amputation; Transfemoral Amputation; Blood Loss

Outcome Measures

Primary Outcomes (1)

• Total blood loss calculated using Nadler's approach

  To calculate this outcome the following information is needed: gender, weight, height, hemoglobin value before surgery (accepted timespan 4 weeks before surgery to day of surgery), hemoglobin value on the third day post surgery, and the number of blood transfusions (from day of surgery to third postoperative day).

  Day 1- Day3

Secondary Outcomes (7)

• Blood transfusion

  Day 1- Day 3

• Intraoperative blood loss

  Day 1

• Length of stay

  Day 1 - To discharge or date of death, whichever comes first, with a maxium of 52 weeks

• Complications during admission

  Day 1 - To Discharge or date of death, whichever comes first, with a maxium of 52 weeks

• Risk of mortality ≤30 days

  Day 1 - Day 30

Other Outcomes (5)

• Risk of re-operation ≤ 1 year

  Day 1 - Day 365

• Risk of mortality ≤ 1 year

  Day 1 - Day 365

• Prosthesis user ≤ 1 year

  Day 1 - Day 365

Study Arms (2)

Transfemoral amputation performed with tourniquet application

EXPERIMENTAL

Group 1:Randomized to procedure with Tourniquet application Sterile wash to groin and placement of sterile tourniquet. The amputation level approximately 10-15 cm above the upper edge of patella is marked and the anterior and posterior flaps are measured and drawn out. The leg is lifted, and the tourniquet is inflated. The pressure is set to 250 mmHg. Starting time is noted. Incision through skin, fascia and musculature. The femoral vessels are clamped, cut and ligated. With an oscillating saw the femoral bone is cut, and the leg can be removed The tourniquet is deflated. Tourniquet time is noted. Rest of procedure as listed in arm2 Weight of the leg is noted. Weight of surgical swabs is noted, to estimate intraoperative blood loss.

Device: Tourniquet

Transfemoral amputation performed without tourniquet application

NO INTERVENTION

Group 2: Randomized to procedure without Tourniquet The amputation level approximately 10-15 cm above the upper edge of patella is marked and the anterior and posterior flaps are measured and drawn out. Incision through skin, fascia and musculature. The femoral vessels are clamped, cut and ligated. With an oscillating saw the femoral bone is cut, and the leg can be removed. The edge of the femoral bone is rasped smooth. A myodesis is performed, attaching the adductor muscle to the end of the femoral bone. Nervus Ischiadicus is dissected as proximal as possible and protected within a purse string suture to avoid development of neuroma. Ligation of bleeding vessels. Fascia and skin is closed with sutures. A soft compression bandage is applied to the stump. * Weight of the leg is noted. * Weight of surgical swabs is noted, to estimate intraoperative blood loss.

Interventions

Tourniquet DEVICE

Tourniquet use in transfemoral amputation.

Transfemoral amputation performed with tourniquet application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Speak and understand Danish and able to give informed consent
• ≥18 years of age
• Indication for first transfemoral amputation (intact femur)

You may not qualify if:

• Bilateral amputation in same procedure
• Femoral amputation revision (non-intact femur)
• Malignant disease as main cause of amputation
• Not possible to place tourniquet correctly (surgeon assessment)
• Acute trauma
• Planned surgery with surgeon charged less than second year residents.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (1)

• Brix ATH, Nymark T, Schmal H, Lindberg-Larsen M. Pneumatic tourniquet versus no tourniquet in transfemoral amputation - a study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2022 Dec 13;23(1):1088. doi: 10.1186/s12891-022-06000-6.

  PMID: 36514077 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Martin Lindberg-Larsen, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding Participants and staff not attendant in the room will be blinded. The use of tourniquet will not be visible in the patient records but recorded directly in the REDCap Database. A standard phrase to describe the surgical procedure will be used in the patient record. Deviations and adverse events will be described. Participants will be able to be informed by the procedure after 6 months.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD Student

Model Details: Randomized, prospective, two-arm, blinded trial. Superiority-design Allocation 1:1 Eligible patients will be randomized to transfemoral surgery with or without the application of a sterile pneumatic tourniquet.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 22, 2022
• Study Start: October 10, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)