Blood Loss, SurgicalNCT02631889
Study to Assess the Effectiveness of Transcollation Technology to Reduce Bleeding in Lung Surgery
A study testing Transcollation technology and Traditional electrocautery in people with Blood Loss, Surgical, run by University of Roma La Sapienza.
Trial summary
Major lung resection is one of the most common procedures performed in thoracic surgery, but it may involve considerable bleeding and the occasional need for a transfusion and/or reoperation for bleeding in specific cases. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Transcollation technology and Traditional electrocautery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be considered for enrollment, patients must:
- be aged ≥ 18 years (of either gender)
- have provided written informed consent prior to participation in the study
- undergoing to major lung surgery with an open approach.
Who cannot join
- To be considered for enrollment, patients must not:
- rethoracotomy
- presence of pleural adhesions
- coagulitive disorders or disease
- have a known immune system disorder or immunodeficiency
- be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue [lung or parts of lymph nodes] for biological research may occur in the same patients)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Randomized, Controlled Study to Assess the Effectiveness of Transcollation Technology to Reduce Bleeding in Lung Surgery
Major lung resection is one of the most common procedures performed in thoracic surgery, but it may involve considerable bleeding and the occasional need for a transfusion and/or reoperation for bleeding in specific cases. In addition, lysis of pleural-parenchymal adhesions and dissection can represent a challenge in patients who have undergone chemotherapy and/or radiation therapy, and in patients with bronchiectasis or COPD. Several intraoperative methods have been used to manage blood loss, including topical haemostatic agents, bipolar sealers or electrocautery. Transcollation technology (TT) consists of a disposable bipolar sealer that uses a radiofrequency coagulation system to deliver a saline solution that provides haemostatic sealing of soft tissue and bone and provides localized cooling without charring. Blood loss reduction has been previously described in several fields of surgery.
The primary end-point of the proposed trial is to assess if the ability of Transcollation Technology in reducing the proportion of patients showing bleeding perioperatively within the setting of a prospective randomized controlled trial.
The secondary end-point is to assess if Transcollation Technology is able to improve postoperative outcomes reducing the length of hospital stay.
Read the detailed description
Study participation will start at signature of informed consent and each subject will be assessed preoperatively, within 4 weeks before surgery. A patient information leaflet will form the basis of discussions with the patient before written informed consent is obtained.
Patients will be evaluated intra-operatively, at 24 and 48 hours after surgery, and at discharge.
At the preoperative visit, the following information will be recorded on the patient's Case Report Form by a specialist Registrar:
- Patient number
- Patient initials
- Date of visit
- Demography (date of birth, sex, height, and weight)
- Preoperative FEV1 and % predicted FEV1
- Co-morbidities (chronic obstructive pulmonary disease [yes/no], current smoking habit [yes/no])
- levels of hemoglobin (preoperative, postoperative, 24 h, 48 h and discharged)
- perioperative complication.
Interventions
Patients undergoing Major Lung Surgery will be randomly assigned to one of two management strategies before the starting of the operation:
- Electrocautery Using routine instrument for hilar dissection, hemostasis and lisys of eventual pleural adhesions.
- Transcollation Technology Using Transcollation Technology for hilar dissection, hemostasis and lisys of eventual pleural adhesions.
Randomization Patients will be randomized in a 1:1 ratio to Transcollation technology (TT) or electrocautery. Patients will be allocated to the two different groups following a block randomization with sealed envelopes. This study is open-label: patients, investigators.
Allocation concealment The nature of the treatment precludes blinding of the surgeon administering the intervention. However, allocating, monitoring and measurement of all primary and secondary endpoints will be made by a dedicated investigator without the knowledge of, or reference to, the treatment allocation (electrocautery or Transcollation technology).
A dedicated investigator will provide a series of sealed envelopes, each containing a randomized treatment allocation. The operating surgeon will ascertain the treatment allocation for each eligible patient by opening the next available sealed randomization envelope. For each patient, the opened envelope will be attached to the Case Report Form for statistical analysis.
Sample Size Group sample sizes of 77 and 77 achieve 90% power to detect a difference of 65,0 ml of chest drain fluid at 24 h between the null hypothesis that both group means of chest drain fluid are 425,0 ml and the alternative hypothesis that the mean of group 2 is 360,0 ml with known group standard deviations of 124,0 ml, with a significance level (alpha) of 0,05 using a two-sided two-sample t-test. We consider a 10% of drop-out then we will recruit 170 patients.
- Conditions
- Blood Loss, Surgical
- Being tested
- Transcollation technology, Traditional electrocautery
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcollation technologyDevice
The use transcollation technology for dissection during lung surgery
Traditional electrocauteryDevice
The use of traditional Electrocautery for dissection during Lung Surgery
| Study group | Role | What they receive |
|---|---|---|
| Transcollation technology | Experimental | the use of transcollation technology for hilium dissection during Lung surgery Receives: Device: Transcollation technology |
| Traditional Electrocautery | Active comparator | The use of electrocautery for hilium dissection during lung surgery Receives: Device: Traditional electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss, Milliliters (mL)
The mean quantity of chest drain fluids at 24 hours of patients in the Transcollation technology (TT) group compared with electrocautery group.
Measured: 24 hrs
Secondary outcomes (1)
Blood loss (g/dl)
hemoglobin level in the blood compared to the pre-operative level
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Ibrahim, University of Roma La Sapienza
- Investigators
- Erino A Rendina, Professor, Study chair, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631889
- Sponsor's protocol ID
- V1/2015
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
S Hammond J, Muirhead W, Zaitoun AM, Cameron IC, Lobo DN. Comparison of liver parenchymal ablation and tissue necrosis in a cadaveric bovine model using the Harmonic Scalpel, the LigaSure, the Cavitron Ultrasonic Surgical Aspirator and the Aquamantys devices. HPB (Oxford). 2012 Dec;14(12):828-32. doi: 10.1111/j.1477-2574.2012.00547.x. Epub 2012 Aug 26.
PubMed 23134184Uchiyama A, Miyoshi K, Nakamura K. VIO soft-coagulation system for major pulmonary resections: results in 68 patients with primary lung cancer. Gen Thorac Cardiovasc Surg. 2011 Mar;59(3):175-8. doi: 10.1007/s11748-010-0709-5. Epub 2011 Mar 30.
PubMed 21448793Litle VR, Swanson SJ. Postoperative bleeding: coagulopathy, bleeding, hemothorax. Thorac Surg Clin. 2006 Aug;16(3):203-7, v. doi: 10.1016/j.thorsurg.2006.05.010.
PubMed 17004547Falez F, Meo A, Panegrossi G, Favetti F, La Cava F, Casella F. Blood loss reduction in cementless total hip replacement with fibrin spray or bipolar sealer: a randomised controlled trial on ninety five patients. Int Orthop. 2013 Jul;37(7):1213-7. doi: 10.1007/s00264-013-1903-8. Epub 2013 May 18.
PubMed 23685830
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study to Assess the Effectiveness of Transcollation Technology to Reduce Bleeding in Lung Surgery
- ClinicalTrials.gov ID
- NCT02631889
- Acronym / sponsor ID
- V1/2015
- Conditions
- Blood Loss, Surgical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major lung resection is one of the most common procedures performed in thoracic surgery, but it may involve considerable bleeding and the occasional need for a transfusion and/or reoperation for bleeding in specific cases. In addition, lysis of pleural-parenchymal adhesions and dissection can represent a challenge in patients who have undergone chemotherapy and/or radiation therapy, and in patients with bronchiectasis or COPD. Several intraoperative methods have been used to manage blood loss, including topical haemostatic agents, bipolar sealers or electrocautery. Transcollation technology (TT) consists of a disposable bipolar sealer that uses a radiofrequency coagulation system to deliver a saline solution that provides haemostatic sealing of soft tissue and bone and provides localized cooling without charring. Blood loss reduction has been previously described in several fields of surgery.
The primary end-point of the proposed trial is to assess if the ability of Transcollation Technology in reducing the proportion of patients showing bleeding perioperatively within the setting of a prospective randomized controlled trial.
The secondary end-point is to assess if Transcollation Technology is able to improve postoperative outcomes reducing the length of hospital stay.
Detailed description
Study participation will start at signature of informed consent and each subject will be assessed preoperatively, within 4 weeks before surgery. A patient information leaflet will form the basis of discussions with the patient before written informed consent is obtained.
Patients will be evaluated intra-operatively, at 24 and 48 hours after surgery, and at discharge.
At the preoperative visit, the following information will be recorded on the patient's Case Report Form by a specialist Registrar:
- Patient number
- Patient initials
- Date of visit
- Demography (date of birth, sex, height, and weight)
- Preoperative FEV1 and % predicted FEV1
- Co-morbidities (chronic obstructive pulmonary disease [yes/no], current smoking habit [yes/no])
- levels of hemoglobin (preoperative, postoperative, 24 h, 48 h and discharged)
- perioperative complication.
Interventions
Patients undergoing Major Lung Surgery will be randomly assigned to one of two management strategies before the starting of the operation:
- Electrocautery Using routine instrument for hilar dissection, hemostasis and lisys of eventual pleural adhesions.
- Transcollation Technology Using Transcollation Technology for hilar dissection, hemostasis and lisys of eventual pleural adhesions.
Randomization Patients will be randomized in a 1:1 ratio to Transcollation technology (TT) or electrocautery. Patients will be allocated to the two different groups following a block randomization with sealed envelopes. This study is open-label: patients, investigators.
Allocation concealment The nature of the treatment precludes blinding of the surgeon administering the intervention. However, allocating, monitoring and measurement of all primary and secondary endpoints will be made by a dedicated investigator without the knowledge of, or reference to, the treatment allocation (electrocautery or Transcollation technology).
A dedicated investigator will provide a series of sealed envelopes, each containing a randomized treatment allocation. The operating surgeon will ascertain the treatment allocation for each eligible patient by opening the next available sealed randomization envelope. For each patient, the opened envelope will be attached to the Case Report Form for statistical analysis.
Sample Size Group sample sizes of 77 and 77 achieve 90% power to detect a difference of 65,0 ml of chest drain fluid at 24 h between the null hypothesis that both group means of chest drain fluid are 425,0 ml and the alternative hypothesis that the mean of group 2 is 360,0 ml with known group standard deviations of 124,0 ml, with a significance level (alpha) of 0,05 using a two-sided two-sample t-test. We consider a 10% of drop-out then we will recruit 170 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcollation technology | Experimental | Device: Transcollation technologythe use of transcollation technology for hilium dissection during Lung surgery |
| Traditional Electrocautery | Active comparator | Device: Traditional electrocauteryThe use of electrocautery for hilium dissection during lung surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be considered for enrollment, patients must:
Key exclusion criteria (6 listed)
- To be considered for enrollment, patients must not:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcollation technologyThe use transcollation technology for dissection during lung surgery | Device | Transcollation technology |
| Traditional electrocauteryThe use of traditional Electrocautery for dissection during Lung Surgery | Device | Traditional Electrocautery |
Primary outcome
Blood Loss, Milliliters (mL)
Time frame: 24 hrs
The mean quantity of chest drain fluids at 24 hours of patients in the Transcollation technology (TT) group compared with electrocautery group.
1 secondary outcome
Blood loss (g/dl)
Time frame: 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Background: PubMed 23134184S Hammond J, Muirhead W, Zaitoun AM, Cameron IC, Lobo DN. Comparison of liver parenchymal ablation and tissue necrosis in a cadaveric bovine model using the Harmonic Scalpel, the LigaSure, the Cavitron Ultrasonic Surgical Aspirator and the Aquamantys devices. HPB (Oxford). 2012 Dec;14(12):828-32. doi: 10.1111/j.1477-2574.2012.00547.x. Epub 2012 Aug 26.
- Background: PubMed 21448793Uchiyama A, Miyoshi K, Nakamura K. VIO soft-coagulation system for major pulmonary resections: results in 68 patients with primary lung cancer. Gen Thorac Cardiovasc Surg. 2011 Mar;59(3):175-8. doi: 10.1007/s11748-010-0709-5. Epub 2011 Mar 30.
- Background: PubMed 17004547Litle VR, Swanson SJ. Postoperative bleeding: coagulopathy, bleeding, hemothorax. Thorac Surg Clin. 2006 Aug;16(3):203-7, v. doi: 10.1016/j.thorsurg.2006.05.010.
- Background: PubMed 23685830Falez F, Meo A, Panegrossi G, Favetti F, La Cava F, Casella F. Blood loss reduction in cementless total hip replacement with fibrin spray or bipolar sealer: a randomised controlled trial on ninety five patients. Int Orthop. 2013 Jul;37(7):1213-7. doi: 10.1007/s00264-013-1903-8. Epub 2013 May 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erino A Rendina, Professor study chair
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A study testing Transcollation technology and Traditional electrocautery in people with Blood Loss, Surgical, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohsen ibrahim, Profssor (+393487325912, mohsen.ibrahim@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss, Milliliters (mL) (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631889, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.