Head and Neck NeoplasmsRIPC-HNCNCT02548377

Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial

A study testing Remote ischemic preconditioning in people with Head and Neck Neoplasms, run by Aarhus University Hospital Skejby at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Neoplasms
What is being tested?: Remote ischemic preconditioning
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteDenmark
Study dates: 29 Sep 2015to 26 Feb 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus.
Will undergo tumor resection and immediate free flap reconstruction at Aarhus University Hospital, Denmark.
The reconstruction is planned with a single free flap.

Who cannot join

Arterial and/or venous thromboembolism within the last three months.
The reconstruction is planned with more than one free flap.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Centre for Hemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Aarhus N, 8200

Other trials in Denmark

About this study

Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet.

Blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. These blood samples will be analyzed for clotting properties and markers of inflammation.

Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography.

Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.

Conditions: Head and Neck Neoplasms
Being tested: Remote ischemic preconditioning, Sham
Keywords: Head and Neck Neoplasms, Surgical Flaps, Ischemic Preconditioning, Hemostasis, Thrombosis, Immune System, Reperfusion Injury
Medical subject headings: Head and Neck Neoplasms, Thrombosis, Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remote ischemic preconditioningProcedure or surgery
ShamProcedure or surgery

Study groups in NCT02548377
Study group	Role	What they receive
Remote ischemic preconditioning	Experimental	Four 5-minute cycles of upper extremity ischemia, each separated by five minutes of reperfusion. The treatment will be carried out with a tourniquet inflated to 200 mmHg during general anaesthesia prior to flap ischemia and transfer. Receives: Procedure: Remote ischemic preconditioning
Sham	Sham comparator	The tourniquet will be attached to the patient's upper extremity but never inflated. Receives: Procedure: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer.
Measured: Blood samples will be analyzed immediately. Data will be assessed and presented within five years.

Secondary outcomes (5)

Acute effects on secondary hemostasis: Plasma samples will be analyzed by standard coagulation assays.
Measured: Plasma samples will be analyzed immediately. Data will be assessed and presented within five years.
Acute effects on fibrinolysis: Plasma samples will be analyzed for markers of fibrinolysis.
Measured: Data will be analyzed, assessed, and presented within five years.
Acute effects on global hemostasis: Plasma samples will be analyzed with the thrombin generation assay.
Measured: Data will be analyzed, assessed, and presented within five years.
Acute effects on systemic inflammation: Plasma samples will be analyzed for complement, acute-phase proteins, cytokines, and leukocytes.
Measured: Data will be analyzed, assessed, and presented within five years.
Effects on complication rates: Flap complications, systemic complications, morbidity and mortality.
Measured: Follow-up is 30 days from the operation. Data will be obtained from visits to the outpatient clinic and by patient chart review. Data will be analyzed, assessed, and presented within five years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 201526 Feb 2018

First posted14 Sep 2015 (estimated)
Study start29 Sep 2015
Primary completion28 Nov 2017
Study completion26 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
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: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02548377
Sponsor's protocol ID: RIPC-HNC
Acronym: RIPC-HNC
Status last verified: Mar 2018
First submitted: 9 Sep 2015
Last updated: 5 Mar 2018
Results posted: No
Data monitoring committee: No

Publications

Taylor GI, Palmer JH. The vascular territories (angiosomes) of the body: experimental study and clinical applications. Br J Plast Surg. 1987 Mar;40(2):113-41. doi: 10.1016/0007-1226(87)90185-8.
PubMed 3567445
Chubb DP, Taylor GI, Ashton MW. True and 'choke' anastomoses between perforator angiosomes: part II. dynamic thermographic identification. Plast Reconstr Surg. 2013 Dec;132(6):1457-1464. doi: 10.1097/01.prs.0000434407.73390.82.
PubMed 24281576
Selber JC, Angel Soto-Miranda M, Liu J, Robb G. The survival curve: factors impacting the outcome of free flap take-backs. Plast Reconstr Surg. 2012 Jul;130(1):105-113. doi: 10.1097/PRS.0b013e318254b1b9.
PubMed 22418714
Khouri RK, Cooley BC, Kunselman AR, Landis JR, Yeramian P, Ingram D, Natarajan N, Benes CO, Wallemark C. A prospective study of microvascular free-flap surgery and outcome. Plast Reconstr Surg. 1998 Sep;102(3):711-21. doi: 10.1097/00006534-199809030-00015.
PubMed 9727436
Culliford AT 4th, Spector J, Blank A, Karp NS, Kasabian A, Levine JP. The fate of lower extremities with failed free flaps: a single institution's experience over 25 years. Ann Plast Surg. 2007 Jul;59(1):18-21; discussion 21-2. doi: 10.1097/01.sap.0000262740.34106.1b.
PubMed 17589253
Olsson E, Svartling N, Asko-Seljavaara S, Lassila R. Activation of coagulation and fibrinolysis during reconstructive microsurgery in patients with cancer. Microsurgery. 2001;21(5):208-13. doi: 10.1002/micr.1040.
PubMed 11494394
Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
PubMed 3769170
Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.
PubMed 12460865
Schmidt MR, Smerup M, Konstantinov IE, Shimizu M, Li J, Cheung M, White PA, Kristiansen SB, Sorensen K, Dzavik V, Redington AN, Kharbanda RK. Intermittent peripheral tissue ischemia during coronary ischemia reduces myocardial infarction through a KATP-dependent mechanism: first demonstration of remote ischemic perconditioning. Am J Physiol Heart Circ Physiol. 2007 Apr;292(4):H1883-90. doi: 10.1152/ajpheart.00617.2006. Epub 2006 Dec 15.
PubMed 17172279
Kerendi F, Kin H, Halkos ME, Jiang R, Zatta AJ, Zhao ZQ, Guyton RA, Vinten-Johansen J. Remote postconditioning. Brief renal ischemia and reperfusion applied before coronary artery reperfusion reduces myocardial infarct size via endogenous activation of adenosine receptors. Basic Res Cardiol. 2005 Sep;100(5):404-12. doi: 10.1007/s00395-005-0539-2. Epub 2005 Jun 17.
PubMed 15965583
Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.
PubMed 20189026
Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.
PubMed 24203849
Dickson EW, Reinhardt CP, Renzi FP, Becker RC, Porcaro WA, Heard SO. Ischemic preconditioning may be transferable via whole blood transfusion: preliminary evidence. J Thromb Thrombolysis. 1999 Aug;8(2):123-9. doi: 10.1023/a:1008911101951.
PubMed 10436142
Lim SY, Yellon DM, Hausenloy DJ. The neural and humoral pathways in remote limb ischemic preconditioning. Basic Res Cardiol. 2010 Sep;105(5):651-5. doi: 10.1007/s00395-010-0099-y. Epub 2010 May 7.
PubMed 20449597
Addison PD, Neligan PC, Ashrafpour H, Khan A, Zhong A, Moses M, Forrest CR, Pang CY. Noninvasive remote ischemic preconditioning for global protection of skeletal muscle against infarction. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1435-43. doi: 10.1152/ajpheart.00106.2003. Epub 2003 Jun 5.
PubMed 12791590

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Head and Neck Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02548377
Acronym / sponsor ID: RIPC-HNC / RIPC-HNC
Conditions: Head and Neck Neoplasms
Keywords: Head and Neck Neoplasms, Surgical Flaps, Ischemic Preconditioning, Hemostasis, Thrombosis, Immune System, Reperfusion Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Aarhus University Hospital SkejbyUniversity, hospital or other
Study start: 29 Sep 2015 (actual)
Primary completion: 28 Nov 2017 (actual)
Study completion: 26 Feb 2018 (actual)
First posted: 14 Sep 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.

Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet.

Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography.

Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Remote ischemic preconditioning	Experimental	Procedure: Remote ischemic preconditioningFour 5-minute cycles of upper extremity ischemia, each separated by five minutes of reperfusion. The treatment will be carried out with a tourniquet inflated to 200 mmHg during general anaesthesia prior to flap ischemia and transfer.
Sham	Sham comparator	Procedure: ShamThe tourniquet will be attached to the patient's upper extremity but never inflated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus.
Will undergo tumor resection and immediate free flap reconstruction at Aarhus University Hospital, Denmark.
The reconstruction is planned with a single free flap.

Key exclusion criteria (2 listed)

Arterial and/or venous thromboembolism within the last three months.
The reconstruction is planned with more than one free flap.

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
Remote ischemic preconditioning	Procedure or surgery	Remote ischemic preconditioning
Sham	Procedure or surgery	Sham

Primary outcome

Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer.
Time frame: Blood samples will be analyzed immediately. Data will be assessed and presented within five years.

5 secondary outcomes

Acute effects on secondary hemostasis: Plasma samples will be analyzed by standard coagulation assays.
Time frame: Plasma samples will be analyzed immediately. Data will be assessed and presented within five years.
Acute effects on fibrinolysis: Plasma samples will be analyzed for markers of fibrinolysis.
Time frame: Data will be analyzed, assessed, and presented within five years.
Acute effects on global hemostasis: Plasma samples will be analyzed with the thrombin generation assay.
Time frame: Data will be analyzed, assessed, and presented within five years.
Acute effects on systemic inflammation: Plasma samples will be analyzed for complement, acute-phase proteins, cytokines, and leukocytes.
Time frame: Data will be analyzed, assessed, and presented within five years.
Effects on complication rates: Flap complications, systemic complications, morbidity and mortality.
Time frame: Follow-up is 30 days from the operation. Data will be obtained from visits to the outpatient clinic and by patient chart review. Data will be analyzed, assessed, and presented within five years.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
Background: PubMed 3567445Taylor GI, Palmer JH. The vascular territories (angiosomes) of the body: experimental study and clinical applications. Br J Plast Surg. 1987 Mar;40(2):113-41. doi: 10.1016/0007-1226(87)90185-8.
Background: PubMed 24281576Chubb DP, Taylor GI, Ashton MW. True and 'choke' anastomoses between perforator angiosomes: part II. dynamic thermographic identification. Plast Reconstr Surg. 2013 Dec;132(6):1457-1464. doi: 10.1097/01.prs.0000434407.73390.82.
Background: PubMed 22418714Selber JC, Angel Soto-Miranda M, Liu J, Robb G. The survival curve: factors impacting the outcome of free flap take-backs. Plast Reconstr Surg. 2012 Jul;130(1):105-113. doi: 10.1097/PRS.0b013e318254b1b9.
Background: PubMed 9727436Khouri RK, Cooley BC, Kunselman AR, Landis JR, Yeramian P, Ingram D, Natarajan N, Benes CO, Wallemark C. A prospective study of microvascular free-flap surgery and outcome. Plast Reconstr Surg. 1998 Sep;102(3):711-21. doi: 10.1097/00006534-199809030-00015.
Background: PubMed 17589253Culliford AT 4th, Spector J, Blank A, Karp NS, Kasabian A, Levine JP. The fate of lower extremities with failed free flaps: a single institution's experience over 25 years. Ann Plast Surg. 2007 Jul;59(1):18-21; discussion 21-2. doi: 10.1097/01.sap.0000262740.34106.1b.
Background: PubMed 11494394Olsson E, Svartling N, Asko-Seljavaara S, Lassila R. Activation of coagulation and fibrinolysis during reconstructive microsurgery in patients with cancer. Microsurgery. 2001;21(5):208-13. doi: 10.1002/micr.1040.
Background: PubMed 3769170Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
Background: PubMed 12460865Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.
Background: PubMed 17172279Schmidt MR, Smerup M, Konstantinov IE, Shimizu M, Li J, Cheung M, White PA, Kristiansen SB, Sorensen K, Dzavik V, Redington AN, Kharbanda RK. Intermittent peripheral tissue ischemia during coronary ischemia reduces myocardial infarction through a KATP-dependent mechanism: first demonstration of remote ischemic perconditioning. Am J Physiol Heart Circ Physiol. 2007 Apr;292(4):H1883-90. doi: 10.1152/ajpheart.00617.2006. Epub 2006 Dec 15.
Background: PubMed 15965583Kerendi F, Kin H, Halkos ME, Jiang R, Zatta AJ, Zhao ZQ, Guyton RA, Vinten-Johansen J. Remote postconditioning. Brief renal ischemia and reperfusion applied before coronary artery reperfusion reduces myocardial infarct size via endogenous activation of adenosine receptors. Basic Res Cardiol. 2005 Sep;100(5):404-12. doi: 10.1007/s00395-005-0539-2. Epub 2005 Jun 17.
Background: PubMed 20189026Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.
Background: PubMed 24203849Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.

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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.

Anne-Mette Hvas, M.D., Ph.D. study chair

Aarhus University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Remote ischemic preconditioning in people with Head and Neck Neoplasms, run by Aarhus University Hospital Skejby at 1 site in Denmark.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer. (time frame: Blood samples will be analyzed immediately. Data will be assessed and presented within five years.). 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 NCT02548377, which also lists 25 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 5 Mar 2018.